Status:
UNKNOWN
Trial for MicroPort's DCB
Lead Sponsor:
Shanghai MicroPort Medical (Group) Co., Ltd.
Conditions:
Coronary Artery In-stent Restenosis
Eligibility:
All Genders
18-75 years
Phase:
NA
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 coron...
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....
Eligibility Criteria
Inclusion
- General
- 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
- 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
- General
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2025
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT04386213
Start Date
September 1 2020
End Date
July 31 2025
Last Update
May 13 2020
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