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

• ClinicalTrials.gov Identifier: NCT02944890
• Recruitment Status: Completed
• First Posted: October 26, 2016
• Last Update Posted: July 29, 2019
• Sponsor: ZhuHai Cardionovum Medical Device Co., Ltd.
• Collaborator: R&G Pharma Studies Co.,Ltd.
• Information provided by (Responsible Party): ZhuHai Cardionovum Medical Device Co., Ltd.

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
Coronary Restenosis	Device: Drug Eluting Balloon Catheters(RESTORE DEB）; Device: Drug Eluting Balloon Catheters(SeQuent® Please）	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• 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 2016
• Actual Primary Completion Date: June 2018
• Actual Study Completion Date: May 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 [ Time Frame: 9 months ]

Secondary Outcome Measures :

1. The success rate of intervention treatment: including device success, lesion success and clinical success [ Time Frame: 1-2 days ]
2. Occurrence rate of restenosis in the target lesions [ Time Frame: 9 months after the operation ]
3. Target lesion revascularization (TLR) rate [ Time Frame: 1, 6, 9, and 12 months after the operation ]
4. Target vessel revascularization (TVR) rate [ Time Frame: 1, 6, 9, and 12 months after the operation ]
5. Target lesion failure (TLF) rate [ Time Frame: 1, 6, 9, and 12 months after the operation ]
6. Occurrence rate of major adverse cardiovascular events [ Time Frame: 1, 6, 9, and 12 months after the operation ]
7. All adverse events and severe adverse events [ Time Frame: 1, 6, 9, and 12 months after the operation ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

China, Beijing

Beijing Chaoyang Hospital

Beijing, Beijing, China, 100020

Beijing Anzhen Hospital,Capital Medical University

Beijing, Beijing, China, 100029

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing, China, 100050

Chinese PLA General Hospital

Beijing, Beijing, China, 100853

China, Gansu

The First Hospital of Lanzhou University

Lanzhou, Gansu, China, 730000

China, Hebei

Cangzhou Central Hospital

Cangzhou, Hebei, China, 061001

China, Heilongjiang

Daqing Oilfield General Hospital

Daqing, Heilongjiang, China, 163000

China, Jiangsu

Nanjing First Hospital

Nanjing, Jiangsu, China, 210006

China, Jilin

The First Hospital of Jilin University

Changchun, Jilin, China, 130021

The Second Hospital of Jilin University

Changchun, Jilin, China, 130041

China, Shaanxi

Tangdu Hospital

Xi'an, Shaanxi, China, 710038

China, Tianjin

Tianjin Chest Hospital

Tianjin, Tianjin, China, 30051

China, Zhejiang

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China, 310009

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chen Y, Gao L, Qin Q, Chen S, Zhang J, Chen H, Wang L, Jin Z, Zheng Y, Zhang Z, Li H, Li X, Fu G, Chen L, Sun Z, Wang Y, Jin Q, Cao F, Guo J, Zhao Y, Guan C, Li W, Xu B; RESTORE ISR China Investigators. Comparison of 2 Different Drug-Coated Balloons in In-Stent Restenosis: The RESTORE ISR China Randomized Trial. JACC Cardiovasc Interv. 2018 Dec 10;11(23):2368-2377. doi: 10.1016/j.jcin.2018.09.010.

• Responsible Party: ZhuHai Cardionovum Medical Device Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02944890
• Other Study ID Numbers: RG01W-1101
• First Posted: October 26, 2016
• Last Update Posted: July 29, 2019
• Last Verified: July 2017

Additional relevant MeSH terms:

Coronary Restenosis; Coronary Stenosis; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases