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

Prospective, Multi-center, Randomized First-in-man Trial Examining the Safety and Efficacy of BuMA Supreme eG (Electro Grafting) Based Biodegradable Polymer Sirolimus-eluting Stent and Resolute Integrity Zotarolimus-eluting Durable Polymer Stent in Patients With de Novo Coronary Artery Stenosis.

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.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: BuMA Supreme Biodegradable drug coating coronary stent system; Device: Resolute Integrity durable polymer stent system

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bonheiden, Belgium
    • Imelda Hospital
  • Chaleroi, Belgium
    • CHU Chaleroi
  • Genk, Belgium
    • Oost-limburg Hospital
• Netherlands
  • Amsterdam, Netherlands
    • AMC
  • Amsterdam, Netherlands
    • OLVG
  • Groningen, Netherlands
    • UMCG
  • Rotterdam, Netherlands
    • Maasstad Hospital
• Portugal
  • Almada, Portugal
    • Hospita; Garcia de Orta
  • Lisboa, Portugal
    • Santa Maria University Hospital
  • Oporto, Portugal
    • Gaia/Espinho Hospital Centers
• Spain
  • Madrid, Spain
    • University Hospital Madrid
  • Vigo, Spain
    • Hospital Álvaro Cunqueiro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BuMA Supreme Biodegradable drug coating coronary stent system; Implant BuMA Supreme stent only	Device: BuMA Supreme Biodegradable drug coating coronary stent system
Active Comparator: Resolute Integrity durable polymer stent system; Implant Resolute stent	Device: Resolute Integrity durable polymer stent system

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiographic endpoint	Acute Lumen Gain (mm);	9 and 12 month
Angiographic endpoint	MLD (mm) post procedure and at 9 months;	9 and 12 month
Angiographic endpoint	Diameter Stenosis (%) post procedure and at 9 months;	9 and 12 month
Angiographic endpoint	Binary Restenosis (DS ≥50%) at 9 months	9 and 12 month
Clinical endpoint	Acute success (device and procedural success)	9 and 12 month
Cinical endpoint	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).	9 and 12 month
Clinical endpoint	Myocardial infarction (Q-wave, Non q-wave) at all time points.	9 and 12 month
Clinical endpoint	Any revascularization at all time points.	9 and 12 month
Clinical endpoint	Stent thrombosis according to the ARC definitions up to 12 months follow-up.	9 and 12 month

Collaborators and Investigators

• Sponsor: Sino Medical Sciences Technology Inc.
• Investigators: Principal Investigator: Clemens von.Birgelen, MD,Phd, Medisch Spectrum Twente (MST), Enschede, the Netherlands; Principal Investigator: Manel Sabate, MD,Phd, Clinic university hospital Barcelona, Spain; Study Chair: Patrick W.Serruys, MD,Phd, Interventional Cardiology, Thorax center, Erasmus MC, Rotterdam

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: September 4, 2014
• First Submitted That Met QC Criteria: September 10, 2014
• First Posted (Estimate): September 11, 2014

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 24, 2020
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Coronary Stenosis
• Other Study ID Numbers: PIONEER

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No