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

• ClinicalTrials.gov Identifier: NCT02236975
• Recruitment Status: Unknown
• First Posted: September 11, 2014
• Last Update Posted: August 19, 2016
• Sponsor: Sino Medical Sciences Technology Inc.
• Information provided by (Responsible Party): Sino Medical Sciences Technology Inc.

Study Description

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.

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 Design

• 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.
• Study Start Date: April 2015
• Estimated Primary Completion Date: November 2016
• Estimated Study Completion Date: November 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Angiographic endpoint [ Time Frame: 9 and 12 month ]
   Acute Lumen Gain (mm);
2. Angiographic endpoint [ Time Frame: 9 and 12 month ]
   MLD (mm) post procedure and at 9 months;
3. Angiographic endpoint [ Time Frame: 9 and 12 month ]
   Diameter Stenosis (%) post procedure and at 9 months;
4. Angiographic endpoint [ Time Frame: 9 and 12 month ]
   Binary Restenosis (DS ≥50%) at 9 months
5. Clinical endpoint [ Time Frame: 9 and 12 month ]
   Acute success (device and procedural success)
6. 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).
7. Clinical endpoint [ Time Frame: 9 and 12 month ]
   Myocardial infarction (Q-wave, Non q-wave) at all time points.
8. Clinical endpoint [ Time Frame: 9 and 12 month ]
   Any revascularization at all time points.
9. Clinical endpoint [ Time Frame: 9 and 12 month ]
   Stent thrombosis according to the ARC definitions up to 12 months follow-up.

Eligibility Criteria

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

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

Contacts and Locations

Sponsors and Collaborators

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

More Information

• Responsible Party: Sino Medical Sciences Technology Inc.
• ClinicalTrials.gov Identifier: NCT02236975
• Other Study ID Numbers: PIONEER
• First Posted: September 11, 2014
• Last Update Posted: August 19, 2016
• Last Verified: August 2016

Additional relevant MeSH terms:

Coronary Artery Disease; Coronary Stenosis; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chlorhexidine; Anti-Infective Agents, Local; Anti-Infective Agents; Disinfectants