Compare the Efficacy and Safety of RESTORE DEB and SeQuent® Please in Chinese Patient With Coronary In-stent Restenosis

July 25, 2019 updated by: ZhuHai Cardionovum Medical Device Co., Ltd.

A Multicenter, Randomized, Controlled Study to Compare the Efficacy and Safety of 2 Types of Drug Eluting Balloon Catheters (RESTORE DEB and SeQuent® Please) in Chinese Patient With Coronary In-stent Restenosis (ISR)

The purpose of this study is to evaluate the safety and efficacy of Paclitaxel drug eluting balloons (RESTORE DEB, 3μg/mm2 balloon surface area ) for success of intervention treatment and maintaining the vessels unobstructed in the treatment of coronary in-stent restenosis compared with a product of the same category (SeQuent® Please).

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.
242

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
      • Beijing, Beijing, China, 100050
        • Beijing Friendship hospital, Capital Medical University
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital
      • Beijing, Beijing, China, 100020
        • Beijing Chaoyang Hospital
      • Beijing, Beijing, China, 100029
        • Beijing Anzhen Hospital，Capital Medical University
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • The First Hospital of Lanzhou University
    • Hebei
      • Cangzhou, Hebei, China, 061001
        • Cangzhou Central Hospital
    • Heilongjiang
      • Daqing, Heilongjiang, China, 163000
        • Daqing Oilfield General Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Nanjing First Hospital
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
      • Changchun, Jilin, China, 130041
        • The Second Hospital of Jilin University
    • Shaanxi
      • Xi'an, Shaanxi, China, 710038
        • Tangdu Hospital
    • Tianjin
      • Tianjin, Tianjin, China, 30051
        • Tianjin Chest Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital School of Medicine, Zhejiang 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Related to the patients:

  1. Age ≥18 years old
  2. Patients agree to receive follow-ups in month-1, 6, 9 and 12, and receive angiography in month-9.
  3. Patients are able to understand the objectives of the study mentally and in language. Patients should indicate sufficient compliance to the study, and acknowledge all risks and benefits by signing the informed consent form.
  4. Patients with stable angina pectoris, or unstable angina pectoris, or old myocardial infarction, or proved asymptomatic regional myocardial ischemia

  5. Patients suitable to receive coronary revascularization of any type (including balloon angioplasty, stent implantation or coronary artery bypass grafting)

    Related to the diseases:

  6. Restenosis Mehran type I-III after stent implantation (including bare metal stents, stents with inert coating, and stents with active coating) for the first time
  7. Diameter of the stent with restenosis should be 2.5-4.0mm (included). Length of the stenosis lesion should be no more than 26mm, and diameter stenosis before operation should be ≥70%, or ≥50% with the evidence of ischemia.
  8. One subject is allowed to have 2 target lesions at most, and 2 Paclitaxel drug balloons for dilation.
  9. The distance between lesions which require intervention and the target lesions must be >10mm.

Exclusion Criteria:

Related to the patients:

  1. Pregnant or lactating women, or women who plan to get pregnant within 12 months or refuse to take effective contraceptives.
  2. The patients are participating in any other clinical trials before reaching the primary endpoints.
  3. The patients have a life expectancy of less than 12 months, or it would be difficult to finish follow-ups within 12 months.
  4. The patients had cerebral stroke within 6 months before being included, or have a history of peptic ulcer or gastrointestinal bleeding in the past 6 months, or the patients have a bleeding tendency according to the investigator.
  5. Patients with a history of leukopenia (white blood cell count <3×109/L for more than 3 days) or neutropenia (ANC<1000/mm3 for more than 3 days) or thrombocytopenia (platelet <100,000/mm3)
  6. Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate Aspirin or Clopidogrel
  7. Patients with renal insufficiency (eGFR<30mL/min)
  8. Patients who are known to be allergic to Paclitaxel
  9. Patients who had myocardial infarction within 1 week before being included
  10. Patients who had heart transplantation
  11. Patients with severe congestive heart failure or NYHA grade IV heart failure
  12. Patients with severe valvular heart disease

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

    Related to the diseases:

  14. Patients with evidence of extensive thrombosis in the target vessel before intervention
  15. Patients with total occlusion indicating TIMI 0 blood flow at the target lesion (Mehran type IV stenosis)
  16. Patients with multiple lesions (≥3) requiring percutaneous coronary intervention treatment in the same artery
  17. Patients with lesions requiring intervention treatment in 3 vessels
  18. The diameter of the branch lesions in the target lesion ≥2.5mm
  19. Patients already treated with CABG after in-stent restenosis
  20. LM lesions and Ostial lesion within 5mm to the root aorta

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: Single

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: RESTORE DEB
Conduct Drug Eluting Balloon Catheters(RESTORE DEB）
Device: Drug Eluting Balloon Catheters(RESTORE DEB）
Active Comparator: SeQuent® Please
Conduct Drug Eluting Balloon Catheters(SeQuent® Please）
Device: Drug Eluting Balloon Catheters(SeQuent® Please）

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
Time Frame
In-segment late lumen loss of the target lesion
Time Frame: 9 months
9 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
Time Frame
The success rate of intervention treatment: including device success, lesion success and clinical success
Time Frame: 1-2 days
1-2 days
Occurrence rate of restenosis in the target lesions
Time Frame: 9 months after the operation
9 months after the operation
Target lesion revascularization (TLR) rate
Time Frame: 1, 6, 9, and 12 months after the operation
1, 6, 9, and 12 months after the operation
Target vessel revascularization (TVR) rate
Time Frame: 1, 6, 9, and 12 months after the operation
1, 6, 9, and 12 months after the operation
Target lesion failure (TLF) rate
Time Frame: 1, 6, 9, and 12 months after the operation
1, 6, 9, and 12 months after the operation
Occurrence rate of major adverse cardiovascular events
Time Frame: 1, 6, 9, and 12 months after the operation
1, 6, 9, and 12 months after the operation
All adverse events and severe adverse events
Time Frame: 1, 6, 9, and 12 months after the operation
1, 6, 9, and 12 months after the operation

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.
ZhuHai Cardionovum Medical Device 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.
R&G Pharma Studies 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: Yundai Chen, PhD, Chinese PLA General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

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.
May 1, 2016

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.
June 1, 2018

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.
May 1, 2019

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).
October 24, 2016

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.
October 25, 2016

First Posted (Estimate)

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.
October 26, 2016

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.
July 29, 2019

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.
July 25, 2019

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.
July 1, 2017

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.
  • RG01W-1101

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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