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

Primary Purpose

Coronary Artery Disease

Status

Active

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

BuMA Supreme

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 Type

Experimental

Arm Label

BuMA Supreme group

Arm Description

Totally 1000 subjects combined the 220 subjects from randomized controlled trial(RCT) group

Outcomes

Primary Outcome Measures

Target Lesion Failure

Target Lesion Failure(TLF) is defined as cardiac death, target vessel myocardial infarction(MI), or clinically-driven target lesion revascularization (TLR).

Secondary Outcome Measures

Stent implantation success rate

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

Device-oriented Composite Endpoint(DoCE)

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

Patient-oriented Composite Endpoint (PoCE)

Patient-oriented Composite Endpoint is defined as all cause death, all 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

NCT02698852

First Posted

January 5, 2016

Last Updated

September 10, 2021

Sponsor

Sino Medical Sciences Technology Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02698852

Brief Title

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

Acronym

OPC

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, OPC Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Active, not recruiting

Study Start Date

December 2015 (undefined)

Primary Completion Date

May 2019 (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 OPC trial is a prospective, multicenter, single-arm registry trial. 1000 subjects from approximately 40 interventional cardiology centers will be enrolled to evaluate the target lesion failure(TLF) as the primary endpoint at 1 year. 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 Sino medical science(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

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BuMA Supreme group

Arm Type

Experimental

Arm Description

Totally 1000 subjects combined the 220 subjects from randomized controlled trial(RCT) group

Intervention Type

Device

Intervention Name(s)

BuMA Supreme

Intervention Description

Stent platform: cobalt-chromium alloy

Primary Outcome Measure Information:

Title

Target Lesion Failure

Description

Target Lesion Failure(TLF) is defined as cardiac death, target vessel myocardial infarction(MI), or clinically-driven target lesion revascularization (TLR).

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Stent implantation success rate

Description

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

Time Frame

5 years after PCI

Title

Device-oriented Composite Endpoint(DoCE)

Description

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

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 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: