First-in-man Trial Examining the Safety and Efficacy of BuMA Supreme and Resolute Integrity in Patients With de Novo Coronary Artery Stenosis
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ClinicalTrials.gov Identifier: NCT02236975 |
Recruitment Status :
Completed
First Posted : September 11, 2014
Last Update Posted : July 28, 2020
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Coronary Artery Disease | Device: BuMA Supreme Biodegradable drug coating coronary stent system Device: Resolute Integrity durable polymer stent system | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 168 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | 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. |
Actual Study Start Date : | April 2015 |
Actual Primary Completion Date : | November 2016 |
Actual Study Completion Date : | March 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: BuMA Supreme Biodegradable drug coating coronary stent system
Implant BuMA Supreme stent only
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Device: BuMA Supreme Biodegradable drug coating coronary stent system |
Active Comparator: Resolute Integrity durable polymer stent system
Implant Resolute stent
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Device: Resolute Integrity durable polymer stent system |
- Late Lumen Loss [ Time Frame: 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.
- Angiographic endpoint [ Time Frame: 9 and 12 month ]Acute Lumen Gain (mm);
- Angiographic endpoint [ Time Frame: 9 and 12 month ]MLD (mm) post procedure and at 9 months;
- Angiographic endpoint [ Time Frame: 9 and 12 month ]Diameter Stenosis (%) post procedure and at 9 months;
- Angiographic endpoint [ Time Frame: 9 and 12 month ]Binary Restenosis (DS ≥50%) at 9 months
- Clinical endpoint [ Time Frame: 9 and 12 month ]Acute success (device and procedural success)
- Cinical endpoint [ Time Frame: 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).
- Clinical endpoint [ Time Frame: 9 and 12 month ]Myocardial infarction (Q-wave, Non q-wave) at all time points.
- Clinical endpoint [ Time Frame: 9 and 12 month ]Any revascularization at all time points.
- Clinical endpoint [ Time Frame: 9 and 12 month ]Stent thrombosis according to the ARC definitions up to 12 months follow-up.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The subject is at least 18 years of age.
- Clinical evidence of ischemic heart disease and/or a positive territorial functional study.
- 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
- The patient has a planned intervention of a single de-novo lesion in one or two separate major epicardial territories (LAD, LCX or RCA).
- Diameter Stenosis≥50 and<100%.
- 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).
- The target lesion reference diameter must be visually estimated to be ≥2.5 mm and ≤4.5 mm in diameter.
- Written informed consent.
- The patient agrees to the follow-up visits including a 9 month angiographic follow-up.
- Patient must have completed the follow-up phase of any previous study.
Exclusion Criteria:
- 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.
- 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
- Patient suffered from stroke/TIA during the last 6 months.
- LVEF <30%
- 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)
- 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).
- Patient undergoing planned surgery within 6 months with the necessity to stop DAPT.
- Patient requiring oral anticoagulation (Coumadin, Novel Oral Anticoagulant (NOAC))
- History of bleeding diathesis or coagulopathy
- The patient is a recipient of a heart transplant
- Known hypersensitivity or contraindication to aspirin, heparin, antiplatelet medication specified for use in the study, sirolimus, zotarolimus, or cobalt-chromium.
- 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
- The patient is simultaneously participating in another investigational device or drug study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236975
Belgium | |
Imelda Hospital | |
Bonheiden, Belgium | |
CHU Chaleroi | |
Chaleroi, Belgium | |
Oost-limburg Hospital | |
Genk, Belgium | |
Netherlands | |
AMC | |
Amsterdam, Netherlands | |
OLVG | |
Amsterdam, Netherlands | |
UMCG | |
Groningen, Netherlands | |
Maasstad Hospital | |
Rotterdam, Netherlands | |
Portugal | |
Hospita; Garcia de Orta | |
Almada, Portugal | |
Santa Maria University Hospital | |
Lisboa, Portugal | |
Gaia/Espinho Hospital Centers | |
Oporto, Portugal | |
Spain | |
University Hospital Madrid | |
Madrid, Spain | |
Hospital Álvaro Cunqueiro | |
Vigo, Spain |
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 |
Responsible Party: | Sino Medical Sciences Technology Inc. |
ClinicalTrials.gov Identifier: | NCT02236975 |
Other Study ID Numbers: |
PIONEER |
First Posted: | September 11, 2014 Key Record Dates |
Last Update Posted: | July 28, 2020 |
Last Verified: | August 2016 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Coronary Artery Disease Coronary Stenosis Coronary Disease Myocardial Ischemia Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |