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

Primary Purpose

Coronary Artery Disease

Status

Active

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

BuMA Supreme

BuMA™

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Drug eluting stents, Interventional Cardiology

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18-75, male or non-pregnant female
Evidence of non-symptomatic ischemia, stable or non-stable angina pectoris or past MI
Target lesion is primary and de-novo coronary artery disease
The target lesion length ≤ 60 mm, diameter 2.25mm-5.0mm (visually estimated)
Lesion diameter stenosis ≥70% (visually estimated)
For each target lesion, same stent implantation only
Acceptable candidate for coronary artery bypass grafting (CABG)
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:

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

Sites / Locations

Zhongshan Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BuMA Supreme group

BuMA™ group

Arm Description

This group contains 319 subjects. Among them, 220 subjects will be implanted with regular specifications and 99 subjects with narrower, wider or longer ones.

This group contains 220 subjects.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Stent implantation success rate

The stent implantation success rate includes device success, lesion success and clinical success.

Binary restenosis rate

Binary restenosis was defined in every segment (proximal, distal, and stent) as a >50% diameter.

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).

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).

Device-oriented Composite Endpoint (DoCE)

Device-oriented Composite Endpoint is defined as cardiac death, target vessel MI, or clinically-driven target lesion revascularization (TLR).

Patient-oriented Composite Endpoint (PoCE)

Patient-oriented Composite Endpoint is defined as all cause death, all myocardial ischemia (MI), or any revascularization.

Academic Research Consortium(ARC) defined stent thrombosis

Definite and probable stent thrombosis during acute, subacute, later and very late phase.

Full Information

NCT ID

NCT02698839

First Posted

January 5, 2016

Last Updated

September 10, 2021

Sponsor

Sino Medical Sciences Technology Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02698839

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 2015 (Actual)

Primary Completion Date

March 2018 (Actual)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sino Medical Sciences Technology Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Drug eluting stents, Interventional Cardiology

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

539 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BuMA Supreme group

Arm Type

Experimental

Arm Description

This group contains 319 subjects. Among them, 220 subjects will be implanted with regular specifications and 99 subjects with narrower, wider or longer ones.

Arm Title

BuMA™ group

Arm Type

Active Comparator

Arm Description

This group contains 220 subjects.

Intervention Type

Device

Intervention Name(s)

BuMA Supreme

Intervention Description

Stent platform: cobalt-chromium alloy

Intervention Type

Device

Intervention Name(s)

BuMA™

Intervention Description

Stent platform: stainless steel

Primary Outcome Measure Information:

Title

in-stent Late Lumen Loss, 9M

Description

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).

Time Frame

QCA at 9-month follow-up window

Secondary Outcome Measure Information:

Title

Stent implantation success rate

Description

The stent implantation success rate includes device success, lesion success and clinical success.

Time Frame

5 years after PCI

Title

Binary restenosis rate

Description

Binary restenosis was defined in every segment (proximal, distal, and stent) as a >50% diameter.

Time Frame

9 months

Title

in-segment LLL

Description

to evaluate the in-sigment Late Lumen Loss (LLL) at 9-month after stent implantation as assessed by off-line quantitative coronary angiography (QCA).

Time Frame

9 months

Title

diameter stenosis degree

Description

to compare the lumen diameter at 9-month after stent implantation with the baseline diameter as assessed by off-line quantitative coronary angiography (QCA).

Time Frame

9 months

Title

Device-oriented Composite Endpoint (DoCE)

Description

Device-oriented Composite Endpoint is defined as cardiac death, target vessel MI, or clinically-driven target lesion revascularization (TLR).

Time Frame

1, 6, 12 month, and annually up to 5 years post procedure

Title

Patient-oriented Composite Endpoint (PoCE)

Description

Patient-oriented Composite Endpoint is defined as all cause death, all myocardial ischemia (MI), or any revascularization.

Time Frame

1, 6, 12 month, and annually up to 5 years post procedure

Title

Academic Research Consortium(ARC) defined stent thrombosis

Description

Definite and probable stent thrombosis during acute, subacute, later and very late phase.

Time Frame

5 years after PCI

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-75, male or non-pregnant female Evidence of non-symptomatic ischemia, stable or non-stable angina pectoris or past MI Target lesion is primary and de-novo coronary artery disease The target lesion length ≤ 60 mm, diameter 2.25mm-5.0mm (visually estimated) Lesion diameter stenosis ≥70% (visually estimated) For each target lesion, same stent implantation only Acceptable candidate for coronary artery bypass grafting (CABG) 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: Acute MI within 1 week Chronic total occlusion(TIMI 0), left main lesion, intervention-required three-vessel lesions, branch vessel diameter ≥ 2.5mm and bypass lesion More than 3 stents required Patients refuse to be implanted stent Calcified lesion failed in pre-dilation, twisted lesion and lesion unsuitable for stent delivery and expansion In-stent restenosis Planned percutaneous coronary intervention (PCI) within 3 months post procedure Other stents implanted within 1 year Severe heart failure (NYHA above III) or left ventricle ejection fraction (EF) <40% Renal function damage, blood creatinine > 176.82 μmol/L Bleeding tendency, active peptic ulcer disease, cerebral or subarachnoid hemorrhage, cerebral apoplexy within half year and contraindication for any anti-platelet or anticoagulation agents Allergic to drugs or agents used in stent or protocol (PLGA, sirolimus, aspirin, clopidogrel, contrast agent, cobalt, nickel, chromium, iron, wolfram et. al.) Life expectation < 12 months Have not reached the primary end point when participating in other trial Poor compliance to the protocol Heart implantation cases

Overall Study Officials: