Scoring-Balloon Angioplasty and Sirolimus-Eluting Balloon Angioplasty for the Treatment of Diffuse, Small Vessel Coronary Artery Disease (SCA-DEB Study) (SCA-DEB)

January 8, 2024 updated by: Dobrin Vassilev, University National Heart Hospital
This is a prospective, single-center, single-arm study to evaluate the feasibility and safety of the combination of Scoring-Balloon Angioplasty and Sirolimus-Eluting Balloon Angioplasty for the treatment of diffuse, small vessel coronary artery disease. The objective of the study is to demonstrate the feasibility and safety of the combination of scoring-balloon angioplasty (SBA) plus sirolimus-eluting balloon angioplasty (SEBA) for diffuse (lesion length ≥20 mm), small vessel (diameter 1.5 mm -2.75 mm) coronary disease.

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.

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.
106

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.
  • Name: Dobrin Vassilev, MD, PhD
  • Phone Number: +3590886846550
  • Email: dobrinv@gmail.com

Study Locations

  • Bulgaria
      • Ruse, Bulgaria, 7000
        • Recruiting
        • Medica Core Heart Hopsital
        • Contact:

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. Patientsaged≥18years.
  2. Presence of epicardial coronary artery disease with lesion length ≥ 20 mm and vessel diameter less than 2.75 mm and more than 1.5 mm with diameter stenosis >50% by visual evaluation.

Exclusion Criteria:

  1. Life expectancy < 2 years
  2. Left ventricular EF ≤40%
  3. Pregnantorlactatingfemales.
  4. Moderate and moderate-to-severe valvular heart disease.
  5. Hemodynamic instability.
  6. Severe renal dysfunction, defined as an eGFR <30 mL/min/1.73 m2
  7. Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, bivalirudin, prasugrel, ticagrelor and drug such as Sirolimus (Rapamycin) or similar drugs or any analogue or derivative, hydrogenated castor oil, PVP or any contrast media.
  8. Patients in whom anti-platelet and/or anti-coagulant therapy are contraindicated.
  9. Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.
  10. Transplant patients.
  11. Patients with calcified lesion requiring other type of treatment such as Rotational Atherectomy.
  12. Unprotected left main coronary artery lesions
  13. Coronary artery spasm in the absence of a significant stenosis.
  14. Patients whose diseased segment cannot be pre-dilated or prepared before drug coated balloon treatment.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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.
Other: Scoring Balloon Angioplasty
Combination of scoring-balloon angioplasty (SBA) plus sirolimus-eluting balloon angioplasty (SEBA) for diffuse (lesion length ≥20 mm), small vessel (diameter 1.5 mm -2.75 mm) coronary disease.
Device: Mozec™ SEB Sirolimus Eluting Rx PTCA Balloon Dilatation Catheter
Combination of scoring-balloon angioplasty (SBA) plus sirolimus-eluting balloon angioplasty (SEBA) for diffuse (lesion length ≥20 mm), small vessel (diameter 1.5 mm -2.75 mm) coronary disease.

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
Major Adverse Cardiovascular Events (MACE)
Time Frame: 12 months
Composite of non-fatal MI, cardiovascular death, and 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
Cardiovascular Death
Time Frame: 3 months, 6 months, 12 months, 24 months, 36 months
Defined as per Academic Research Consortium-2 (ARC-2) criteria
3 months, 6 months, 12 months, 24 months, 36 months
Non-fatal Myocardial Infarction
Time Frame: 3 months, 6 months, 12 months, 24 months, 36 months
Non-fatal myocardial infarction (MI) is defined as per the fourth universal definition of MI
3 months, 6 months, 12 months, 24 months, 36 months
Target Lesion Revascularization (TLR)
Time Frame: 3 months, 6 months, 12 months, 24 months, 36 months
It is defined as repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion
3 months, 6 months, 12 months, 24 months, 36 months
Target Vessel Failure (TVF)
Time Frame: 3 months, 6 months, 12 months, 24 months, 36 months
It is defined as the composite of cardiovascular death, target vessel myocardial infarction and target vessel revascularization
3 months, 6 months, 12 months, 24 months, 36 months
Restenosis
Time Frame: 3 months
Defined as >50% stenosis at the treated segment.
3 months
Major bleeding
Time Frame: 3 months, 6 months, 12 months, 2 years and 3 years
Defined as bleeding that causes hemodynamic instability and/or leads to blood transfusion
3 months, 6 months, 12 months, 2 years and 3 years
Quality of Life Score
Time Frame: Baseline, 3 months, 6 months, 12 months
OverallHealthStatusassessedbyShortFormSurvey(SF-12)
Baseline, 3 months, 6 months, 12 months
Device success
Time Frame: During the procedure
Defined as the ability of the study device to be delivered, dilated, and retrieved from the target lesion
During the procedure

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.
University National Heart Hospital

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.
Meril Life Sciences Pvt. Ltd.

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.
October 1, 2022

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.
October 1, 2024

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.
December 1, 2024

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).
December 25, 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.
January 8, 2024

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.
January 9, 2024

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.
January 9, 2024

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.
January 8, 2024

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.
December 1, 2023

More Information

Terms related to this study

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.
  • SCA-DEB_2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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