A Prospective, Multicenter, Randomized Trial in Evaluating the Safety and Efficacy of the Paclitaxel Drug-coated Coronary Artery Balloon Catheter in Patients With Coronary Artery In-stent Restenosis Compared to SeQuent® Please Paclitaxel Drug-coated Coronary Artery Balloon Catheter

Shanghai MicroPort Medical (Group) Co., Ltd.0 sites216 target enrollmentSeptember 1, 2020

ConditionsCoronary Artery In-stent Restenosis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Coronary Artery In-stent Restenosis
Sponsor: Shanghai MicroPort Medical (Group) Co., Ltd.
Enrollment: 216
Primary Endpoint: In-segment Late Lumen Loss
Status: Not Yet Recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This study is a multicenter, randomized, controlled clinical research and aims to evaluate the safety and efficacy of the paclitaxel drug-coated coronary artery balloon catheter in patients with coronary artery in-stent restenosis compared to seQuent® please paclitaxel drug-coated coronary artery balloon catheter.

Detailed Description

This prospective, multicenter, randomized controlled clinical study is designed to enroll 216 subjects with in-stent restenosis and randomly assign them to the trial and control groups on a 1:1 basis.The experimental group was treated with paclitaxel drug-coated coronary artery balloon catheter, and the control group was treated with SeQuent ® Please paclitaxel balloon catheter, which has been marketed. In-segment late lumen loss 9 months after surgery was the main end point of the study. All subjects were followed up clinically at 1 month, 6 months, 9 months, 1 year and 2 years after the surgery, and were followed up with angiography at 9 months after the surgery.

Registry

clinicaltrials.gov

Start Date

September 1, 2020

End Date

July 31, 2025

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai MicroPort Medical (Group) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•General Inclusion Criteria:
•1.18-75 years of age, males or non-pregnant females; 2.With silent ischemia evidence, patients with stable or unstable angina, or in patients with old myocardial infarction; 3.Restenosis after the first stent implantation, and more than 90 days after the stent implantation; 4.Patients with indications for coronary artery bypass graft surgery; 5.To understand the purpose of testing, voluntary and informed consent, patients undergoing invasive imaging follow-up.
•Angiographic Inclusion Criteria:
•One or two target lesions;
•Restenosis in the stent (including bare stent, permanent coating and biodegradable coating) : Mehran I, II and III stenosis;The diameter of the reference vessel ranges from 2.0mm to 4.0mm, and the length ≤40mm;
•The original stent diameter stenosis before surgery must be ≥70% or ≥50% with local ischemia;
•There should be no more than two lesions requiring interventional treatment, and the distance between the two lesions must be \>10mm.

Exclusion Criteria

•General Exclusion Criteria:
•Within 1 week of any acute myocardial infarction or myocardial enzymes did not return to normal;
•Severe congestive heart failure (NYHA III and above) ,or left ventricular ejection fraction \<30% (ultrasound or left ventricular angiography);
•The unstable arrhythmia, such as high risk ventricular extrasystole and ventricular tachycardia;
•Blood test prompted platelet counts of less than 100x10E9/L or greater than 700x10E9/L, white blood cells than 3x10E9/L; which was judged to be clinically significant by the researchers;
•Preoperative renal function serum creatinine \>2.0mg/DL; receiving hemodialysis;
•Subjects with bleeding tendency, antiplatelet preparation and anticoagulant treatment contraindications, subjects unable to receive antithrombotic treatment, or subjects unable to tolerate DAPT treatment for three months;
•Previous history of peptic ulcer or gastrointestinal bleeding within 6 months;
•Patients with cerebral vascular accident or transient ischemic attack (TIA) within the previous 6 months, or with permanent neurological defects that may lead to non-compliance with the protocol;
•Allergic to aspirin, heparin, contrast agent, polylactic acid polymer and paclitaxel;

Outcomes

Primary Outcomes

In-segment Late Lumen Loss

Time Frame: 9 months after coronary angiography

In-segment Late Lumen Loss

Secondary Outcomes

Clinical success(At time of procedure up to 7 days in hospital)
Procedural success(Immediately after the index procedure)
The number and rate of Thrombosis (per ARC definition)(1 month, 6 months, 9 months, 1 year and 2 years after index procedure)
Device success(during the procedure)
In-segment angiography binary restenosis (ABR, %)(9 months after index procedure)
The number and rate of Target Lesion Revascularization (TLR)(1 month, 6 months, 9 months, 1 year and 2 years after index procedure)
The number and rate of Target Vessel Revascularization (TVR)(1 month, 6 months, 9 months, 1 year and 2 years after index procedure)
Device-oriented composite endpoints (Target Lesion Failure)(1 month, 6 months, 9 months, 1 year and 2 years after index procedure)
Patient-oriented composite endpoint (PoCE)(1 month, 6 months, 9 months, 1 year and 2 years after index procedure)
Death (Cardiac, Non-cardiac)(1 month, 6 months, 9 months, 1 year and 2 years after index procedure)
The number and rate of Myocardial Infarction (MI)(1 month, 6 months, 9 months, 1 year and 2 years after index procedure)
The number and rate of Any Revascularization(1 month, 6 months, 9 months, 1 year and 2 years after index procedure)