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

Coronary Artery Disease Clinical Trial

— RCT  

Official title:

A Prospective, Multicenter Trial Program in China to Evaluate the Efficacy and Safety of BuMA Supreme (eG Grafting) Biodegradable Polymer Sirolimus Eluting Stent in Patients With de Novo Coronary Lesions, RCT Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02698839
• Other study ID #: PIONEER-II, RCT, P01
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: Sino Medical Sciences Technology Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 539
• Est. completion date: December 2025
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• BuMA Supreme
Stent platform: cobalt-chromium alloy
• BuMA™
Stent platform: stainless steel

Locations

Country	Name	City	State
China	Zhongshan Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Sino Medical Sciences Technology Inc.

Country where clinical trial is conducted

China, 

Outcome

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