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

Sponsor
ZhuHai Cardionovum Medical Device Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02944890
Collaborator
R&G Pharma Studies Co.,Ltd. (Industry)
242
Enrollment
14
Locations
2
Arms
36
Duration (Months)
17.3
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Device: Drug Eluting Balloon Catheters(RESTORE DEB）
  • Device: Drug Eluting Balloon Catheters(SeQuent® Please）
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
242 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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)
Study Start Date :
May 1, 2016
Actual Primary Completion Date :
Jun 1, 2018
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

Arm Intervention/Treatment
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）

Outcome Measures

Primary Outcome Measures

  1. In-segment late lumen loss of the target lesion [9 months]

Secondary Outcome Measures

  1. The success rate of intervention treatment: including device success, lesion success and clinical success [1-2 days]

  2. Occurrence rate of restenosis in the target lesions [9 months after the operation]

  3. Target lesion revascularization (TLR) rate [1, 6, 9, and 12 months after the operation]

  4. Target vessel revascularization (TVR) rate [1, 6, 9, and 12 months after the operation]

  5. Target lesion failure (TLF) rate [1, 6, 9, and 12 months after the operation]

  6. Occurrence rate of major adverse cardiovascular events [1, 6, 9, and 12 months after the operation]

  7. All adverse events and severe adverse events [1, 6, 9, and 12 months after the operation]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  1. 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

  2. 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.

  3. One subject is allowed to have 2 target lesions at most, and 2 Paclitaxel drug balloons for dilation.

  4. 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:

  1. Patients with evidence of extensive thrombosis in the target vessel before intervention

  2. Patients with total occlusion indicating TIMI 0 blood flow at the target lesion (Mehran type IV stenosis)

  3. Patients with multiple lesions (≥3) requiring percutaneous coronary intervention treatment in the same artery

  4. Patients with lesions requiring intervention treatment in 3 vessels

  5. The diameter of the branch lesions in the target lesion ≥2.5mm

  6. Patients already treated with CABG after in-stent restenosis

  7. LM lesions and Ostial lesion within 5mm to the root aorta

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing Chaoyang Hospital Beijing Beijing China 100020
2 Beijing Anzhen Hospital,Capital Medical University Beijing Beijing China 100029
3 Beijing Friendship Hospital, Capital Medical University Beijing Beijing China 100050
4 Chinese PLA General Hospital Beijing Beijing China 100853
5 The First Hospital of Lanzhou University Lanzhou Gansu China 730000
6 Cangzhou Central Hospital Cangzhou Hebei China 061001
7 Daqing Oilfield General Hospital Daqing Heilongjiang China 163000
8 Nanjing First Hospital Nanjing Jiangsu China 210006
9 The First Hospital of Jilin University Changchun Jilin China 130021
10 The Second Hospital of Jilin University Changchun Jilin China 130041
11 Tangdu Hospital Xi'an Shaanxi China 710038
12 Tianjin Chest Hospital Tianjin Tianjin China 30051
13 The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang China 310009
14 Sir Run Run Shaw Hospital School of medicine, Zhejiang University Hangzhou Zhejiang China 310016

Sponsors and Collaborators

  • ZhuHai Cardionovum Medical Device Co., Ltd.
  • R&G Pharma Studies Co.,Ltd.

Investigators

  • Principal Investigator: Yundai Chen, PhD, Chinese PLA General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ZhuHai Cardionovum Medical Device Co., Ltd.
ClinicalTrials.gov Identifier:
NCT02944890
Other Study ID Numbers:
  • RG01W-1101
First Posted:
Oct 26, 2016
Last Update Posted:
Jul 29, 2019
Last Verified:
Jul 1, 2017
Additional relevant MeSH terms:
Coronary Restenosis

Study Results

No Results Posted as of Jul 29, 2019