A Safety and Efficacy Study of Dissolve™ in Treatment of Coronary In-stent Restenosis

February 18, 2025 updated by: DK Medical Technology (Suzhou) Co., Ltd.

A Multicenter, Randomized, Controlled Clinical Study to Evaluate the Efficacy and Safety of Dissolve™ Compared to SeQuent® Please in Treatment of Coronary In-stent Restenosis in Chinese Population

The purpose of this study is to evaluate the efficacy and safety of treatment of coronary in-stent restenosis by Paclitaxel-eluting balloon catheter Dissolve™ versus SeQuent®Please, and the reference diameter of coronary artery stenosis is 2.5mm-4.0mm and the length ≤ 26mm.

Study Overview

Status

Status

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

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 (Actual)

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.
260

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 Locations

  • China
      • Beijing, China
        • Beijing Friendship Hospital, Capital Medical University
      • Beijing, China
        • Beijing Hospital
      • Beijing, China
        • Peking Union Medical College Hospital
      • Beijing, China
        • Beijing AnZhen Hospital, Capital Medical University
      • Beijing, China
        • Fuwai Hospital, Chinese Academy of Medical Sciences
      • Beijing, China
        • Peking University People's Hospital, Capital Medical University
      • Changsha, China
        • Xiangya Hospital of Central South University
      • Chengdu, China
        • West China Hospital, Sichuan University
      • Dalian, China
        • The Second Affiliated Hospital of Dalian Medical University
      • Dalian, China
        • The First Affiliated Hospital of Dalian Medical University
      • Daqing, China
        • General Hospital of Daqing Oil Field
      • Hangzhou, China
        • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
      • Hangzhou, China
        • The First Affiliated Hospital of Zhengzhou University
      • Wuhan, China
        • Union Hospital, Tongji Medical College Huazhong University of Science and Technology
      • Yinchuan, China
        • General Hospital of Ningxia Medical University

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Related to the patients:

  1. Age ≥18 years old
  2. Patients who agree to accept the angiography follow-up visit at 9-month and follow up visits at 1-month, 6-month, 9-month, 1-year, 2-year, 3-year, 4-year and 5-year
  3. Patients with stable angina, unstable angina, old myocardial infarction or proven asymptomatic ischemia

  4. Patients who can receive any kind of coronary revascularization (including balloon angioplasty, stent implantation or coronary artery bypass grafting)

    Related to lesion:

  5. Restenosis after the first stent implant (including bare metal stents, stents with inert coating, and stents with active coating): Type Mehran I, Type II and Type III; the reference blood vessel diameter is 2.5 mm-4.0 mm, length ≤ 26mm
  6. Before surgery, stenosis diameter must be ≥ 70% or ≥ 50% and accompanied by ischemia
  7. The distance between other lesion requires interventional therapy and the target lesion must be > 10mm
  8. One subject is allowed to have 2 target lesions at most, and 1 paclitaxel drug balloon for each lesion for dilation
  9. Residual stenosis must be ≤ 30% after pre-dilatation, and dissection must be ≤ NHLBI type B

Exclusion Criteria:

Related to patients

  1. Pregnant or lactating women, or women who plan to get pregnant within 12 months or refuse to take effective contraceptives
  2. Patients with cardiogenic shock
  3. The patients had cerebral stroke within 6 months before being included, or have a history of peptic ulcer or gastrointestinal bleeding, or the patients have a bleeding tendency according to the investigator. Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate aspirin or clopidogrel. Patients who are not able to tolerate and comply with dual antiplatelet therapy for at least 3 months after operation
  4. Patients who have Myocardial Infarction with thrombus or coronary slow flow symptoms and require immediate intervention
  5. Patients who had ST-Elevation Myocardial Infarction within 1 week before being included
  6. Patients with severe congestive heart failure or NYHA grade IV heart failure
  7. Patients with moderate or severe valvular heart disease
  8. Patients who had heart transplantation
  9. Patients with renal insufficiency (eGFR < 30mL/min)
  10. The patients have a life expectancy of less than 12 months, or it would be difficult to finish follow-ups within 12 months.
  11. The patients are participating in any other clinical trials before reaching the primary endpoints

  12. Patients who are unsuitable for the study according to the investigator due to other reasons

    Related to the Lesion:

  13. Patients with total occlusion at the target lesion
  14. Lesion which cannot be treated by percutaneous transluminal coronary angioplasty (PTCA) or percutaneous intervention (PCI)
  15. Reference vessel diameter < 2.0mm
  16. Patients with multiple lesions (≥ 3) requiring percutaneous coronary intervention treatment in the same artery
  17. 3-vessel disease that all need to be intervened
  18. The diameter of the branch lesions in the target lesion ≥ 2.5mm
  19. LM lesions and Ostial lesion within 5mm to the root aorta

  20. Non-target lesion was not intervened successfully before target lesions being intervened

    Related to concomitant therapy:

  21. Patients cannot tolerate aspirin and/or clopidogrel and or tricagrelor, patients with the history of neutrocytopenia or thrombocytopenia, or patients with severe hypohepatia and prohibited to take clopidogrel
  22. Patients known allergic to paclitaxel
  23. Patients known allergic to contrast materials

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: 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.
Experimental: Dissolve™
Device: Dissolve™
Dissolve™ are to be used in the trial
Active Comparator: SeQuent®Please
Device: SeQuent®Please
SeQuent®Please are to be used in the trial

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
In-segment Late Lumen Loss
Time Frame: From the end of procedure to 9 months after the procedure
In-segment late lumen loss is defined as the change in minimal lumen diameter (MLD) within the margins of the device and 5 mm proximal and 5 mm distal to the device from post-procedure to 9 months by angiography.
From the end of procedure to 9 months after the procedure

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
Device success rate of the interventional therapy
Time Frame: From the start of index procedure to end of index procedure
Successful delivery and use of the assigned balloon at the intended target lesion and successful withdrawal of the delivery system with attainment of final residual stenosis of less than 30% and TIMI 3 blood flow by visual estimation.
From the start of index procedure to end of index procedure
Lesion success rate of the interventional therapy
Time Frame: From the start of index procedure to end of index procedure
Attainment of final residual stenosis of target lesion less than 30% and TIMI 3 blood flow by visual estimation.
From the start of index procedure to end of index procedure
Clinical success rate of the interventional therapy
Time Frame: 7 days after the procedure
Achievement of final residual stenosis of less than 30% by visual estimation with successful delivery and use of assigned balloon at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel Myocardial Infarction (MI) or repeat Target lesion revascularization (TLR).
7 days after the procedure
Rate of restenosis in the target lesions
Time Frame: 9 months after the procedure
Restenosis is defined as stenosis > 30% by angiography
9 months after the procedure
TLR rate
Time Frame: 9 months after the procedure
9 months after the procedure
Target vessel revascularization (TVR) rate
Time Frame: 9 months after the procedure
9 months after the procedure
Target lesion failure (TLF) rate
Time Frame: 9 months after the procedure
9 months after the procedure
Rate of major adverse cardiovascular events
Time Frame: 1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure
1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure
Rate of all adverse events and severe adverse events
Time Frame: 1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after the procedure
1 month, 6 months, 9 months, 1 year, 2 years, 3 years, 4 years and 5 years after 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.
DK Medical Technology (Suzhou) Co., Ltd.

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.
Core Medical (Beijing) Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shubin Qiao, Chinese Academy of Medical Sciences, Fuwai Hospital

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.
February 22, 2018

Primary Completion (Actual)

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.
January 9, 2020

Study Completion (Actual)

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.
April 24, 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 5, 2017

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.
December 10, 2017

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.
December 14, 2017

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 18, 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

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.
  • CL-VP-01

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.

Clinical Trials on Coronary In-stent Restenosis

Clinical Trials on Dissolve™

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings