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

Phase 2

Completed

• Conditions: Coronary Artery Disease
• Interventions: Device: BuMA Supreme Biodegradable drug coating coronary stent system; Device: Resolute Integrity durable polymer stent system

• Registration Number: NCT02236975
• Lead Sponsor: Sino Medical Sciences Technology Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-10
• Study First Posted: 2014-09-11
• Study Start: 2015-04
• Status Verified: 2016-08
• Primary Completion: 2016-11
• Study Completion: 2019-03
• Last Update Submitted: 2020-07-24
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BuMA Supreme Biodegradable drug coating coronary stent system	BuMA Supreme Biodegradable drug coating coronary stent system	Implant BuMA Supreme stent only
Resolute Integrity durable polymer stent system	Resolute Integrity durable polymer stent system	Implant Resolute stent

Primary Outcome Measures

Name	Time	Method
Late Lumen Loss	Up to 9 month	The primary endpoint is in-stent Late Lumen Loss (LLL) at 9 months after stent implantation as assessed by off-line QCA.

Secondary Outcome Measures

Name	Time	Method
Cinical endpoint	9 and 12 month	Device-oriented Composite Endpoints (DoCE) at 1, 9 and 12 months and its individual components. (Device-oriented Composite Endpoint is defined as Cardiac Death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated Target Lesion Revascularization).
Angiographic endpoint	9 and 12 month	Binary Restenosis (DS ≥50%) at 9 months
Clinical endpoint	9 and 12 month	Stent thrombosis according to the ARC definitions up to 12 months follow-up.

Trial Locations

Locations (12)

UMCG; 🇳🇱 Groningen, Netherlands

Maasstad Hospital; 🇳🇱 Rotterdam, Netherlands

Santa Maria University Hospital; 🇵🇹 Lisboa, Portugal

Hospita; Garcia de Orta; 🇵🇹 Almada, Portugal

Gaia/Espinho Hospital Centers; 🇵🇹 Oporto, Portugal

CHU Chaleroi; 🇧🇪 Chaleroi, Belgium

University Hospital Madrid; 🇪🇸 Madrid, Spain

Hospital Álvaro Cunqueiro; 🇪🇸 Vigo, Spain

Imelda Hospital; 🇧🇪 Bonheiden, Belgium

AMC; 🇳🇱 Amsterdam, Netherlands

Oost-limburg Hospital; 🇧🇪 Genk, Belgium

OLVG; 🇳🇱 Amsterdam, Netherlands