First-in-man Trial Examining the Safety and Efficacy of BuMA Supreme and Resolute Integrity in Patients With de Novo Coronary Artery Stenosis

NCT ID: NCT02236975

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2019-03-31

Brief Summary

Prospective, multi-center, randomized 1:1, single blind trial using BuMA Supreme versus Resolute Integrity conducted in approximately 14 interventional cardiology centers in The Netherlands, Belgium, Spain and Portugal.

Clinical follow-up will occur at 1, 9 and 12 months post-stent implantation. All patients will undergo repeat angiography at 9 months follow-up. QCA assessment will be performed at baseline (pre- and post-procedure) and at 9 months follow-up.

Conditions

Coronary Artery Disease

Study Design

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

Study Groups

BuMA Supreme Biodegradable drug coating coronary stent system

Implant BuMA Supreme stent only

Group Type: EXPERIMENTAL

BuMA Supreme Biodegradable drug coating coronary stent system

Intervention Type: DEVICE

Resolute Integrity durable polymer stent system

Implant Resolute stent

Group Type: ACTIVE_COMPARATOR

Resolute Integrity durable polymer stent system

Intervention Type: DEVICE

Interventions

BuMA Supreme Biodegradable drug coating coronary stent system

Intervention Type: DEVICE

Resolute Integrity durable polymer stent system

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. The subject is at least 18 years of age.

2. Clinical evidence of ischemic heart disease and/or a positive territorial functional study.

3. Documented stable angina pectoris (Canadian Cardiovascular Society (CCS) Classification 1, 2, 3 or 4) or unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), or documented silent ischemia

4. The patient has a planned intervention of a single de-novo lesion in one or two separate major epicardial territories (LAD, LCX or RCA).

5. Diameter Stenosis≥50 and<100%.

6. The visually estimated target lesion must be able to be covered by a single BuMA Supreme stent or a single Resolute Integrity stent (for available sizes refer to tables 1 and 2, page 20 and 21).

7. The target lesion reference diameter must be visually estimated to be ≥2.5 mm and ≤4.5 mm in diameter.

8. Written informed consent.

9. The patient agrees to the follow-up visits including a 9 month angiographic follow-up.

10. Patient must have completed the follow-up phase of any previous study.

Exclusion Criteria

1. Female of child bearing potential (age <50 years and last menstruation within the last 12 months). Subjects with age <50 who underwent tubal ligation, ovariectomy or hysterectomy can be included.

2. Evidence of ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of procedure

3. Patient suffered from stroke/TIA during the last 6 months.

4. LVEF <30%

5. Platelet count <100,000 cells/mm3 or >400,000 cells/mm3, a WBC of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)

6. Known renal insufficiency (e.g. serum creatinine >2.5mg/dL, or creatinine clearance ≤30 mL/min), or subject on dialysis, or acute kidney failure (as per physician judgment).

7. Patient undergoing planned surgery within 6 months with the necessity to stop DAPT.

8. Patient requiring oral anticoagulation (Coumadin, Novel Oral Anticoagulant (NOAC))

9. History of bleeding diathesis or coagulopathy

10. The patient is a recipient of a heart transplant

11. Known hypersensitivity or contraindication to aspirin, heparin, antiplatelet medication specified for use in the study, sirolimus, zotarolimus, or cobalt-chromium.

12. Other medical illness (e.g. cancer, stroke with neurological deficiency) or known history of substance abuse (alcohol, cocaine, heroin etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy

13. The patient is simultaneously participating in another investigational device or drug study

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

Sponsors

Sino Medical Sciences Technology Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clemens von.Birgelen, MD,Phd

Role: PRINCIPAL_INVESTIGATOR

Medisch Spectrum Twente (MST), Enschede, the Netherlands

Manel Sabate, MD,Phd

Role: PRINCIPAL_INVESTIGATOR

Clinic university hospital Barcelona, Spain

Patrick W.Serruys, MD,Phd

Role: STUDY_CHAIR

Interventional Cardiology, Thorax center, Erasmus MC, Rotterdam

Locations

Imelda Hospital

Bonheiden, , Belgium

CHU Chaleroi

Chaleroi, , Belgium

Oost-limburg Hospital

Genk, , Belgium

AMC

Amsterdam, , Netherlands

OLVG

Amsterdam, , Netherlands

UMCG

Groningen, , Netherlands

Maasstad Hospital

Rotterdam, , Netherlands

Hospita; Garcia de Orta

Almada, , Portugal

Santa Maria University Hospital

Lisbon, , Portugal

Gaia/Espinho Hospital Centers

Porto, , Portugal

University Hospital Madrid

Madrid, , Spain

Hospital Álvaro Cunqueiro

Vigo, , Spain

Countries

Belgium; Netherlands; Portugal; Spain

References

Wang R, Kawashima H, Hara H, Gao C, Ono M, Takahashi K, Tu S, Soliman O, Garg S, van Geuns RJ, Tao L, Wijns W, Onuma Y, Serruys PW. Comparison of Clinically Adjudicated Versus Flow-Based Adjudication of Revascularization Events in Randomized Controlled Trials. Circ Cardiovasc Qual Outcomes. 2021 Nov;14(11):e008055. doi: 10.1161/CIRCOUTCOMES.121.008055. Epub 2021 Oct 20.

Reference Type: DERIVED

PMID: 34666500 (View on PubMed)

Other Identifiers

PIONEER

Identifier Type: -

Identifier Source: org_study_id