MagicTouch for Treatment of In-Stent Restenosis in Coronary Artery Lesions (MAGICAL ISR)

February 24, 2025 updated by: Concept Medical Inc.

MagicTouch Sirolimus-coated Balloon for Treatment of In-Stent Restenosis in Coronary Artery Lesions

A Prospective, Multicenter, Randomized, Two-Arm, Single-blind Superiority Trial to Evaluate the Safety and Efficacy of the MagicTouch™ Sirolimus- Coated Balloon in the Treatment of Coronary Drug-Eluting Stent In-Stent Restenosis.

Subjects with prior DES implantation presenting with ISR lesions undergoing PCI will be randomized into two groups: treatment with the MagicTouch™ sirolimus-coated balloon or POBA on a 2:1 basis. Approximately 492 subjects will be enrolled in the randomized study in a maximum of 50 study sites located in the United States.

The goal is to establish the safety and efficacy of the MagicTouch™ sirolimus- coated balloon in treatment of coronary in-stent restenosis (ISR).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All subjects providing informed consent will have their medical history reviewed and will undergo a physical examination, laboratory screen, and a standardized 12-lead ECG within 7 days of procedure. Women of childbearing potential will have a pregnancy test within one week prior to the procedure. If subjects meet the inclusion and exclusion criteria of the study, they will be randomized to one of two treatment groups, and will then undergo treatment with MagicTouch™ sirolimus-coated balloon or POBA of the target ISR lesion, per trial protocol.

One pre-procedure and all post-procedure biomarker blood draws will be sent to a central core laboratory for analysis of troponin T. Evaluation of post-procedural biomarker blood draws in local laboratories are not mandated but may be performed as part of standard of care.

During the index hospitalization, patients will undergo a clinical assessment and 12-lead ECG; and they will have cardiac biomarkers drawn before the intervention to establish baseline biomarker level and confirmation that the biomarkers are falling. At least one post procedure biomarker (core lab) will be drawn at a minimum of 4 hours after PCI as part of the assessment of periprocedural myocardial infarction and significant periprocedural myocardial injury (at 6-8 hour intervals depending on whether the patient remains admitted). If no procedural complications have occurred and there are no signs of ischemia on post-procedure ECG or clinical assessment, the patient may be discharged per local practice and no additional biomarker levels need to be drawn (beyond the protocol-mandated core laboratory draw at a minimum of 4 hours). If the patient remains admitted cardiac biomarkers (core lab) should be drawn every 6-8 hours until at least 2 total post-procedural core laboratory biomarker draws have passed or clinical standard-based biomarker levels have peaked per local labs or the patient is discharged.

After hospital discharge, subjects will be followed at 30 days (+1 week), 6 months (+2 weeks), and 12 months (+1 month) and then 24, 36, 48 and 60 months (+1 month) post procedure. Yearly vital status information will be collected by telephone follow-up. At the 12-month visit, subjects will undergo 12-lead ECG, blood count, coagulation profile and blood chemistry tests. New and ongoing AEs and concomitant medications will also be assessed.

All elective angiograms performed on the target vessel during the 12-month follow-up period should be preceded by a physician evaluation, during which the physician will indicate whether the subject's clinical status warrants revascularization, i.e. the subject has clinical evidence of ischemia. All films, including unscheduled angiograms, are to be sent to the angiographic core laboratory for review. The angiographic core laboratory will be blinded.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
492

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35211
        • Recruiting
        • Cardiology, PC - Princeton Baptist Medical Center
    • Arizona
      • Gilbert, Arizona, United States, 85297
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars - Sinai Medical Center
        • Contact:
        • Contact:
          • Raj Makkar
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Yale University / Yale New Haven Hospital
    • Florida
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • Clearwater Cardiovascular and Interventional Consultants
        • Contact:
          • Bernardo Stein
        • Contact:
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • Cheek-Powell Heart and Vascular Pavilion
        • Contact:
          • Bernardo Stein
      • Gainesville, Florida, United States, 32605
        • Recruiting
        • The Cardiac & Vascular Institute Research Foundation
        • Contact:
        • Contact:
          • Matheen Khuddus
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Tampa General Hospital / University of South Florida
        • Contact:
          • Hiram Bezerra
        • Contact:
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Recruiting
        • Atlanta VA Medical Center
        • Contact:
        • Contact:
          • Rajesh Sachdeva
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Not yet recruiting
        • Beth Israel Deaconess Medical Center
        • Contact:
          • Robert Yeh
        • Contact:
    • Minnesota
      • Coon Rapids, Minnesota, United States, 55433
        • Not yet recruiting
        • Metropolitan Heart and Vascular Institute
        • Contact:
        • Contact:
          • Matthew G Whitbeck
        • Contact:
          • Randall P Stark
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute Foundation
        • Contact:
        • Contact:
          • Yader Sandoval
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Recruiting
        • Cardiology Associates Research, LLC
        • Contact:
          • Barry Bertolet
        • Contact:
    • New Jersey
      • Pomona, New Jersey, United States, 08240
        • Recruiting
        • AtlantiCare Regional Medical Center
        • Contact:
          • Said Ashraf
        • Contact:
    • New York
      • Bronx, New York, United States, 10467
        • Recruiting
        • Montefiore Medical Center - Moses Division
        • Contact:
          • Azeem Latib
        • Contact:
          • Judah Rauch
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University Medical Center/NYPH
        • Contact:
          • Ajay Kirtane
        • Contact:
          • Jeffrey Moses
      • New York, New York, United States, 10010
        • Recruiting
        • VA New York Harbor Healthcare System
        • Contact:
        • Contact:
          • Nathaniel Smilowitz
      • New York City, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Contact:
          • Natalie S. Massenburg
        • Contact:
          • Razzouk Louai
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Contact:
          • Amar Krishnaswamy
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • Oklahoma University Health (OU Health)
        • Contact:
        • Contact:
          • Mohit Pahuja
    • Oregon
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence St. Vincent Medical Center
        • Contact:
        • Contact:
          • Jason Wollmuth
    • South Carolina
      • Greenville, South Carolina, United States, 29605-5601
    • Tennessee
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Dallas, Texas, United States, 75226
        • Recruiting
        • Baylor Scott and White Heart and Vascular Hospital
        • Contact:
        • Contact:
          • Robert Stoler
      • Plano, Texas, United States, 75093
        • Recruiting
        • Baylor Scott & White - The Heart Hospital - Plano
        • Contact:
        • Contact:
          • Karim Al-Azizi
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University and Vascular Institute
        • Contact:
          • Josh Bomabrd
          • Phone Number: 3042851980
        • Contact:
          • Ramesh Daggubati

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject is at least 18 years old
  2. Subject (or legal guardian) understands the trial requirements and treatment procedures and provides written informed consent prior to any trial-specific tests or treatment
  3. Patient with an indication for PCI due to suspected in-stent restenosis
  4. Non-target lesion PCI are allowed in non-target vessels to be treated with approved interventional devices prior to randomization as follows:

Angiographic Inclusion Criteria:

  1. In-stent restenosis after drug-eluting stent implantation(s) in the target lesion (i.e. single and multiple stent layer ISR cases are eligible)
  2. Target lesion must have visually estimated stenosis ≥50% and less than 100% diameter stenosis in symptomatic patients; or a visually estimated target lesion diameter stenosis of ≥70%, or by evidence of ischemia by coronary physiology (fractional flow reserve [FFR] ≤0.80 or non-hyperemic pressure ratio [NHPR] ≤0.89) in absence of symptoms
  3. Successful lesion preparation (residual stenosis <30%), without complications (no or slow flow, flow-limiting dissection, perforation, distal embolization) and without plan for stenting
  4. Target lesion in a native coronary artery
  5. Thrombolysis In Myocardial Infartction (TIMI) grade flow ≥1 in target lesion
  6. Target reference vessel diameter (visual estimation) >2.0 and ≤4.0 mm
  7. Target lesion length (including tandem lesions) ≤36.0 mm (visual estimation) and can be covered by only one balloon
  8. One ISR target lesion (overlapping stents are allowed) to be treated per patient and in single major coronary artery or side branch (reference vessel diameter >2.0 mm)
  9. Other coronary lesions (ISR or non-ISR) in non-target vessel are allowed and may be treated by any approved interventional device, but must be treated successfully prior to randomization

Exclusion Criteria:

General Exclusion Criteria (all must be absent for the patient to be eligible):

  1. STEMI within 72 hours of presentation to the first treating hospital, whether a transfer facility or the study hospital
  2. NSTEACS in whom the biomarkers have not peaked
  3. PCI within the 24 hours prior to the index procedure (not including PCI performed in non-target lesions during the index procedure)
  4. Prior DCB treatment (coronary or off-label peripheral) of target lesion ISR
  5. Cardiogenic shock (defined as persistent hypotension [systolic blood pressure <90 mm Hg] or requiring vasoactive or hemodynamic support, including IABP)
  6. Subject is intubated
  7. Known left ventricular ejection fraction <30%
  8. Relative or absolute contraindication to DAPT for at least 1 month (e.g., planned surgeries that cannot be delayed)
  9. Subject has an indication for chronic oral anticoagulation treatment and a contraindication for concomitant treatment with a P2Y12 inhibitor
  10. If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath
  11. Hemoglobin <9 g/dL
  12. Platelet count <100,000 cells/mm3 or >700,000 cells/mm3
  13. White blood cell count <3,000 cells/mm3
  14. Active infection undergoing treatment
  15. Clinically significant liver disease
  16. Renal insufficiency as defined by estimated glomerular filtration rate (eGFR) to be <30ml/min by the MDRD formula
  17. Active peptic ulcer or active bleeding from any site
  18. Bleeding from any site requiring active medical attention within the prior 8 weeks
  19. History of bleeding diathesis or coagulopathy or likely to refuse blood transfusions
  20. Cerebrovascular accident (CVA) within 3 months or has any permanent neurological defect as a result of CVA

  21. Known allergy to the study device components or protocol-required concomitant medications:

    - sirolimus (as well as other limus drugs, analogues, or similar compounds), aspirin, clopidogrel and prasugrel and ticagrelor, heparin and bivalirudin, or iodinated contrast that cannot be adequately pre-medicated

  22. Any co-morbid condition that may cause non-compliance with the protocol (e.g. dementia, substance abuse, etc.) or reduce life expectancy to <24 months (e.g. cancer, heart failure, lung disease, severe valvular disease)
  23. Patient is participating in or plans to participate in any other investigational drug or device trial that has not reached its primary endpoint
  24. Women who are pregnant or breastfeeding (women of child-bearing potential must have a negative pregnancy test within one week before index procedure)
  25. Women who intend to become pregnant within 12 months after the index procedure
  26. Patient has received an organ transplant or is on a waiting list for an organ transplant
  27. Patient has received chemotherapy within 30 days before the index procedure or scheduled to receive chemotherapy any time after the index procedure
  28. Patient is receiving oral or intravenous immunosuppressive therapy or has known life-limiting immunosuppressive or autoimmune disease. Inhaled steroid and steroid use for contrast- allergy prophylaxis or treatment are allowed

Angiographic Exclusion Criteria (visual estimate) (all must be absent for the patient to be eligible):

  1. More than 1 ISR lesion in the target vessel in segments that cannot be treated by a single 40mm length DCB (see Angiographic Inclusions #5 and #6 above)
  2. ISR lesion in the target vessel in a segment that corresponds to a previously established/documented bare metal stent (BMS)
  3. Unprotected left main lesions >50% or left main intervention
  4. Primary PCI for STEMI
  5. Coronary artery disease judged more suitable for surgical revascularization per guidelines and local heart team discussion
  6. Another lesion in either the target vessel or non-target vessel is present that requires or has a high probability of requiring PCI within 12 months after the index procedure
  7. Prior brachytherapy or DCB treatment of target lesion
  8. Target lesion is a bifurcation restenosis involving both branches of a bifurcation in which the side branch reference vessel diameter is >2.0 mm
  9. Target lesions located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft
  10. Target lesion contains large thrombus
  11. Target lesion is heavily calcified
  12. Target lesion is a chronic total occlusion (or subtotal) without adequate lesion preparation.* Total and subtotal occlusions may be enrolled assuming they can be crossed with a wire and demonstrate TIMI grade 3 flow at the time of randomization.
  13. Diffuse distal disease to target lesion with impaired runoff

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MagicTouch Sirolimus-Coated Balloon
Magic TouchTM is a Sirolimus Coated Balloon catheter intended to be used in coronary applications, treats the atherosclerosis of the coronary arteries by eluting the immunosuppressant agent Sirolimus without leaving behind a metallic scaffold.
Device: Sirolimus Drug Coated Balloon
Magic TouchTM (Concept Medical) is a semi-compliant sirolimus drug coated balloon (SCB) for PCI, based on a polymer-free and nanocarrier based drug delivery technology.
Active Comparator: POBA
plain old balloon angioplasty
Device: Plan balloon Angioplasty (POBA)
Plan balloon used to open clogged or narrow coronary arteries due to underlying atherosclerosis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
TLF (Target Lesion Failure)
Time Frame: 12 months
The composite rate of cardiac death, target-vessel MI (Myocardial Infarction) or ischemia-driven TLR (Target Lesion Revascularization)
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MACE (Major adverse cardiovascular events)
Time Frame: 30 days and 6, 12, 24, 36, 48, and 60 months
composite of cardiovascular mortality, any MI (Myocardial Infarction), and ID-TLR (Ischemia-Driven Target Lesion Revascularization)
30 days and 6, 12, 24, 36, 48, and 60 months
TVF (Target vessel failure)
Time Frame: 30 days and 6, 12, 24, 36, 48, and 60 months
composite of cardiovascular mortality, ID-TVR (Ischemia-Driven Target Vessel Revascularization), and TV-MI (Target Vessel Myocardial Infarction)
30 days and 6, 12, 24, 36, 48, and 60 months
Any revascularization
Time Frame: 30 days and 6, 12, 24, 36, 48, and 60 months
any repeat PCI or CABG
30 days and 6, 12, 24, 36, 48, and 60 months
ID-TLR (Ischemia-Driven Target Lesion Revascularization)
Time Frame: 30 days and 6, 12, 24, 36, 48, and 60 months
Repeat revascularization of the target lesion due to recurrent ischemia
30 days and 6, 12, 24, 36, 48, and 60 months
TLR (Target Lesion Revascularization)
Time Frame: 30 days and 6, 12, 24, 36, 48, and 60 months
Repeat revascularization of the target lesion
30 days and 6, 12, 24, 36, 48, and 60 months
ID-TVR (Ischemia-Driven Target Vessel Revascularization)
Time Frame: 30 days and 6, 12, 24, 36, 48, and 60 months
Repeat revascularization of the target vessel due to recurrent ischemia
30 days and 6, 12, 24, 36, 48, and 60 months
TVR (Target Vessel Revascularization)
Time Frame: 30 days and 6, 12, 24, 36, 48, and 60 months
Repeat revascularization of the target vessel
30 days and 6, 12, 24, 36, 48, and 60 months
All-cause mortality
Time Frame: 30 days and 6, 12, 24, 36, 48, and 60 months
Death from any cause
30 days and 6, 12, 24, 36, 48, and 60 months
Cardiovascular mortality
Time Frame: 30 days and 6, 12, 24, 36, 48, and 60 months
Death due to coronary artery disease or complications of coronary treatment
30 days and 6, 12, 24, 36, 48, and 60 months
Any MI (Myocardial Infarction)
Time Frame: 30 days and 6, 12, 24, 36, 48, and 60 months
Any Myocardial Infarction
30 days and 6, 12, 24, 36, 48, and 60 months
TV-MI (Target Vessel Myocardial Infarction)
Time Frame: 30 days and 6, 12, 24, 36, 48, and 60 months
Myocardial Infarction related to the target vessel
30 days and 6, 12, 24, 36, 48, and 60 months
Q-wave MI (Myocardial Infarction)
Time Frame: 30 days and 6, 12, 24, 36, 48, and 60 months
Myocardial Infarction demonstrated by new pathological Q waves on ECG
30 days and 6, 12, 24, 36, 48, and 60 months
Non-Q-wave MI (Myocardial Infarction)
Time Frame: 30 days and 6, 12, 24, 36, 48, and 60 months
Myocardial Infarction not demonstrated by new pathological Q waves on ECG
30 days and 6, 12, 24, 36, 48, and 60 months
Cardiovascular mortality or MI (Myocardial Infarction)
Time Frame: 30 days and 6, 12, 24, 36, 48, and 60 months
Either cardiovascular death or any Myocardial Infarction
30 days and 6, 12, 24, 36, 48, and 60 months
All-cause mortality or MI (Myocardial Infarction)
Time Frame: 30 days and 6, 12, 24, 36, 48, and 60 months
Either death from any cause or any Myocardial Infarction
30 days and 6, 12, 24, 36, 48, and 60 months
All-cause mortality, MI (Myocardial Infarction), or TVR (Target Vessel Revascularization)
Time Frame: 30 days and 6, 12, 24, 36, 48, and 60 months
Death from any cause, any Myocardial Infarction, or Target Vessel Revascularization
30 days and 6, 12, 24, 36, 48, and 60 months
Any definite or probable target lesion stent thrombosis by ARC (Academic Research Consortium) criteria
Time Frame: 30 days and 6, 12, 24, 36, 48, and 60 months
Definite or probable stent thrombosis in the target lesion according to the ARC (Academic Research Consortium) definition
30 days and 6, 12, 24, 36, 48, and 60 months
Probable target lesion stent thrombosis by ARC (Academic Research Consortium) criteria
Time Frame: 30 days and 6, 12, 24, 36, 48, and 60 months
Probable stent thrombosis in the target lesion according to the ARC definition
30 days and 6, 12, 24, 36, 48, and 60 months
Definite target lesion stent thrombosis by ARC (Academic Research Consortium) criteria
Time Frame: 30 days and 6, 12, 24, 36, 48, and 60 months
Definite stent thrombosis in the target lesion according to the ARC definition
30 days and 6, 12, 24, 36, 48, and 60 months
BARC (Bleeding Academic Research Consortium) type 3-5 bleeding
Time Frame: 30 days and 6, 12, 24, 36, 48, and 60 months
Significant or severe bleeding according to the BARC definition
30 days and 6, 12, 24, 36, 48, and 60 months
Procedure Success
Time Frame: 30 days and 6, 12, 24, 36, 48, and 60 months
ability to deliver the device and achieve a less than 30% residual stenosis by QCA (quantitative coronary angiography) without major complication or bailout stenting
30 days and 6, 12, 24, 36, 48, and 60 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Angina as assessed by SAQ-7 (Seattle Angina Questionnaire)
Time Frame: 30 days, 6, 12, 24, 36, 48 and 60 months
Quality of Life Endpoint, Angina will be assessed at these specified timepoints and prior to any invasive procedure
30 days, 6, 12, 24, 36, 48 and 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Concept Medical Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cardiovascular Research Foundation, New York

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 16, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CM-US-R02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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