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)
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).
Inclusion Criteria:
Related to the patients:
Age ≥18 years old
Patients agree to receive follow-ups in month-1, 6, 9 and 12, and receive angiography in month-9.
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.
Patients with stable angina pectoris, or unstable angina pectoris, or old myocardial infarction, or proved asymptomatic regional myocardial ischemia
Patients suitable to receive coronary revascularization of any type (including balloon angioplasty, stent implantation or coronary artery bypass grafting)
Related to the diseases:
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
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.
One subject is allowed to have 2 target lesions at most, and 2 Paclitaxel drug balloons for dilation.
The distance between lesions which require intervention and the target lesions must be >10mm.
Exclusion Criteria:
Related to the patients:
Pregnant or lactating women, or women who plan to get pregnant within 12 months or refuse to take effective contraceptives.
The patients are participating in any other clinical trials before reaching the primary endpoints.
The patients have a life expectancy of less than 12 months, or it would be difficult to finish follow-ups within 12 months.
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.
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)
Patients who are forbidden to use anticoagulation agents or anti-platelet drugs, and unable to tolerate Aspirin or Clopidogrel
Patients with renal insufficiency (eGFR<30mL/min)
Patients who are known to be allergic to Paclitaxel
Patients who had myocardial infarction within 1 week before being included
Patients who had heart transplantation
Patients with severe congestive heart failure or NYHA grade IV heart failure
Patients with severe valvular heart disease
Patients who are unsuitable for the study according to the investigator due to other reasons
Related to the diseases:
Patients with evidence of extensive thrombosis in the target vessel before intervention
Patients with total occlusion indicating TIMI 0 blood flow at the target lesion (Mehran type IV stenosis)
Patients with multiple lesions (≥3) requiring percutaneous coronary intervention treatment in the same artery
Patients with lesions requiring intervention treatment in 3 vessels
The diameter of the branch lesions in the target lesion ≥2.5mm
Patients already treated with CABG after in-stent restenosis
LM lesions and Ostial lesion within 5mm to the root aorta
Hangzhou, Zhejiang 310009, China