Trial for MicroPort's DCB

NCT ID: NCT04386213

Last Updated: 2020-05-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2025-07-31

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.

Conditions

Coronary Artery In-stent Restenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Paclitaxel Drug-coated Balloon

Group Type: EXPERIMENTAL

coronary artery in-stent restenosis

Intervention Type: DEVICE

treat the petients with coronary artery in-stent restenosis

SeQuent® Please Paclitaxel Drug-coated Balloon

Group Type: ACTIVE_COMPARATOR

coronary artery in-stent restenosis

Intervention Type: DEVICE

treat the petients with coronary artery in-stent restenosis

Interventions

coronary artery in-stent restenosis

treat the petients with coronary artery in-stent restenosis

Intervention Type: DEVICE

Eligibility Criteria

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.

1. One or two target lesions;

2. 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;

3. The original stent diameter stenosis before surgery must be ≥70% or ≥50% with local ischemia;

4. There should be no more than two lesions requiring interventional treatment, and the distance between the two lesions must be >10mm.

Exclusion Criteria

1. Within 1 week of any acute myocardial infarction or myocardial enzymes did not return to normal;

2. Severe congestive heart failure (NYHA III and above) ,or left ventricular ejection fraction <30% (ultrasound or left ventricular angiography);

3. The unstable arrhythmia, such as high risk ventricular extrasystole and ventricular tachycardia;

4. 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;

5. Preoperative renal function serum creatinine >2.0mg/DL; receiving hemodialysis;

6. 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;

7. Previous history of peptic ulcer or gastrointestinal bleeding within 6 months;

8. 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;

9. Allergic to aspirin, heparin, contrast agent, polylactic acid polymer and paclitaxel;

10. The life expectancy of the subjects is less than 12 months;

11. The researcher judged that the subjects had poor compliance and could not complete the study as required;Or for other reasons that the researchers consider inappropriate;

12. Subjects who are participating in any other clinical trial, or who have participated in clinical trials of other drugs or medical devices before being enrolled and have not reached the main study endpoint;

13. Pregnant or breast-feeding female subjects (women who may be pregnant must undergo a pregnancy test 7 days prior to baseline surgery).

1. In-stent restenosis without successful predilatation;

2. Stent restenosis of vein grafts;

3. Bridge stent restenosis;

4. All three vessels were diseased and needed revascularization;

5. Vessel diameter of branch opening in bifurcation lesions ≥2.5mm;

6. Complete occlusion of blood flow at TIMI level 0 (Mehran type IV stenosis);

7. The lesion was located in the left trunk and within 2mm from the opening.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai MicroPort Medical (Group) Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ling Tao

Role: CONTACT

clfeng@microport.com

13636498543

Ling Tao

Role: CONTACT

webmaster@fmmu.edu.cn

029-84775507

Other Identifiers

PROMISE-DCB

Identifier Type: -

Identifier Source: org_study_id