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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02236975
Recruitment Status : Completed
First Posted : September 11, 2014
Last Update Posted : July 28, 2020
Sponsor:
Information provided by (Responsible Party):
Sino Medical Sciences Technology Inc.

Study Description
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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
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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
Arms and Interventions
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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
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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
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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
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Sino Medical Sciences Technology Inc.
Investigators
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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
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases