A Study to Evaluate the Efficacy and Safety of BuMA Supreme Drug Eluting Stent(DES)

Not Applicable

Active, not recruiting

• Conditions: Coronary Artery Disease
• Interventions: Device: BuMA™; Device: BuMA Supreme

• Registration Number: NCT02698839
• Lead Sponsor: Sino Medical Sciences Technology Inc.

Brief Summary

PIONEER-II RCT trial is a prospective, multicenter, randomized, non-inferiority registry trial. 539 subjects from about 40 interventional cardiology centers in China will be enrolled to evaluate In-stent late lumen loss(LLL) as the primary endpoint at 9 months. And all the subjects will be followed up to 5 years to attain the data of the secondary endpoints.

Detailed Description

Realizing even more uniform and complete endothelial coverage, BuMA Supreme™ biodegradable drug coating coronary stent system comprises a new generation of biodegradable drug eluting stent under development by SINOMED. BuMA Supreme™ reconfigures BuMA™ DES utilizing a high caliber cobalt chromium platform coated with rapidly degrading PLGA scaffold.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-01-05
• Study First Submitted QC: 2016-02-29
• Study First Posted: 2016-03-04
• Primary Completion: 2018-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-25
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 539

Inclusion Criteria

1. Age 18-75, male or non-pregnant female
2. Evidence of non-symptomatic ischemia, stable or non-stable angina pectoris or past MI
3. Target lesion is primary and de-novo coronary artery disease
4. The target lesion length ≤ 60 mm, diameter 2.25mm-5.0mm (visually estimated)
5. Lesion diameter stenosis ≥70% (visually estimated)
6. For each target lesion, same stent implantation only
7. Acceptable candidate for coronary artery bypass grafting (CABG)
8. Understand the study purpose, willing to participate and sign the letter of consent, agrees to the follow-up visits including a 9 month angiographic follow-up

Exclusion Criteria

1. Acute MI within 1 week
2. Chronic total occlusion(TIMI 0), left main lesion, intervention-required three-vessel lesions, branch vessel diameter ≥ 2.5mm and bypass lesion
3. More than 3 stents required
4. Patients refuse to be implanted stent
5. Calcified lesion failed in pre-dilation, twisted lesion and lesion unsuitable for stent delivery and expansion
6. In-stent restenosis
7. Planned percutaneous coronary intervention (PCI) within 3 months post procedure
8. Other stents implanted within 1 year
9. Severe heart failure (NYHA above III) or left ventricle ejection fraction (EF) <40%
10. Renal function damage, blood creatinine > 176.82 μmol/L
11. Bleeding tendency, active peptic ulcer disease, cerebral or subarachnoid hemorrhage, cerebral apoplexy within half year and contraindication for any anti-platelet or anticoagulation agents
12. Allergic to drugs or agents used in stent or protocol (PLGA, sirolimus, aspirin, clopidogrel, contrast agent, cobalt, nickel, chromium, iron, wolfram et. al.)
13. Life expectation < 12 months
14. Have not reached the primary end point when participating in other trial
15. Poor compliance to the protocol
16. Heart implantation cases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BuMA™ group	BuMA™	This group contains 220 subjects.
BuMA Supreme group	BuMA Supreme	This group contains 319 subjects. Among them, 220 subjects will be implanted with regular specifications and 99 subjects with narrower, wider or longer ones.

Primary Outcome Measures

Name	Time	Method
in-stent Late Lumen Loss, 9M	QCA at 9-month follow-up window	The primary endpoint is in-stent Late Lumen Loss (LLL) at 9-month after stent implantation as assessed by off-line quantitative coronary angiography (QCA).

Secondary Outcome Measures

Name	Time	Method
diameter stenosis degree	9 months	to compare the lumen diameter at 9-month after stent implantation with the baseline diameter as assessed by off-line quantitative coronary angiography (QCA).
in-segment LLL	9 months	to evaluate the in-sigment Late Lumen Loss (LLL) at 9-month after stent implantation as assessed by off-line quantitative coronary angiography (QCA).
Academic Research Consortium(ARC) defined stent thrombosis	5 years after PCI	Definite and probable stent thrombosis during acute, subacute, later and very late phase.
Stent implantation success rate	5 years after PCI	The stent implantation success rate includes device success, lesion success and clinical success.
Binary restenosis rate	9 months	Binary restenosis was defined in every segment (proximal, distal, and stent) as a \>50% diameter.
Device-oriented Composite Endpoint (DoCE)	1, 6, 12 month, and annually up to 5 years post procedure	Device-oriented Composite Endpoint is defined as cardiac death, target vessel MI, or clinically-driven target lesion revascularization (TLR).
Patient-oriented Composite Endpoint (PoCE)	1, 6, 12 month, and annually up to 5 years post procedure	Patient-oriented Composite Endpoint is defined as all cause death, all myocardial ischemia (MI), or any revascularization.

Trial Locations

Locations (1)

Zhongshan Hospital; 🇨🇳 Shanghai, China