PIONEER III Trial to Assess Safety and Efficacy of the BuMA Supreme™ Drug Coated Coronary Stent in Patients With Coronary Disease



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:20 - Any
Updated:9/5/2018
Start Date:October 13, 2017
End Date:June 2023
Contact:Peter Carlyle
Email:pcarlyle@cardiomedllc.com
Phone:715-455-2370

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A Prospective Global Randomized Trial Assessing the Safety and Efficacy of the BuMA Supreme™ Biodegradable Drug Coated Coronary Stent System for Coronary Revascularization in Patients With Stable Coronary Artery Disease or Non-ST Segment Elevation Acute Coronary Syndromes

The primary objective of this trial is to compare the safety and efficacy of the SINOMED BuMA
Supreme biodegradable coronary stent in patients with up to 3 coronary lesions to either the
XIENCE or Promus durable polymer coronary stents.

This prospective, global, multi-center, randomized 2:1, single blind study will enroll up to
1632 subjects at up to 130 investigational sites in North America, Japan, and Europe.
Subjects will have clinical follow-up in-hospital and at 30 days, 6 months, 12 months, and 2,
3, 4, and 5 years.


Inclusion Criteria:

1. The patient is a male or non-pregnant female ≥20 years of age.

2. The patient has symptomatic ischemic heart disease, including chronic stable angina
(and/or objective evidence of myocardial ischemia on functional study or invasive
fractional flow reserve [FFR] measurement) or acute coronary syndromes (UA or NSTEMI),
that requires elective or urgent percutaneous coronary intervention (PCI).

3. The patient is an acceptable candidate for percutaneous coronary intervention (PCI)
with drug-eluting stents, and for emergent coronary bypass graft (CABG) surgery.

4. The patient is willing to comply with specified follow-up evaluations.

5. The patient or legally authorized representative has been informed of the nature of
the study, agrees to its provisions, and has been provided written informed consent
approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC).

Exclusion Criteria:

1. Pregnant or nursing patients and those who plan pregnancy in the period up to 1 year
following index procedure. Female patients of childbearing potential must have a
negative pregnancy test done within 7 days prior to index procedure per site standard
test.

2. Patients with a history of bleeding diathesis or coagulopathy, contraindications to
anti-platelet and/or anticoagulant therapy, or who will refuse transfusion.

3. Patients who are receiving or will require chronic anticoagulation therapy for any
reason.

4. Known hypersensitivity or contraindication to aspirin, heparin/bivalirudin, ADP
receptor antagonists (clopidogrel, prasugrel, ticagrelor, ticlopidine), cobalt
chromium, 316L stainless steel or platinum, sirolimus or its analogues, and/or
contrast sensitivity that cannot be adequately pre-medicated.

5. ST-segment elevation myocardial infarction (STEMI) at index presentation or within 7
days prior to randomization.

6. Known LVEF <30% or cardiogenic shock requiring pressors or mechanical circulatory
assistance (e.g., intra-aortic balloon pump, left ventricular assist device, other
temporary cardiac support blood pump).

7. Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) <30
mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation or
Cockcroft-Gault formula) or dialysis at the time of screening.

8. Target vessel percutaneous coronary intervention with stent placement in the previous
3 months.

9. Planned elective surgery that would require discontinuation of DAPT within 6 months of
the index procedure.

10. Past or pending heart or any other organ transplant, or on the waiting list for any
organ transplant.

11. Patients who are receiving immunosuppressant therapy, or who have known
immunosuppressive or severe autoimmune disease that will require chronic
immunosuppressive therapy. NOTE: Corticosteroid use is permitted.

12. Known other medical illness or known history of substance abuse that may cause
non-compliance with the protocol, confound data interpretation, or is associated with
a life expectancy of less than 1 year.

13. Current participation in another investigational drug or device study.
We found this trial at
41
sites
Ypsilanti, Michigan 48197
Phone: 734-712-8387
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593 Eddy Street
Providence, Rhode Island 02903
401-444-4000
Phone: 401-444-5324
Rhode Island Hospital Founded in 1863, Rhode Island Hospital in Providence, RI, is a private,...
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Aalst, 9300
Phone: + 32 (0)53 72 44 49
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Anderson, South Carolina 29621
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Baltimore, Maryland 21218
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Birmingham, Alabama 35211
Principal Investigator: Alain Bouchard
Phone: 205-949-5280
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2815 South Seacrest Boulevard
Boynton Beach, Florida 33435
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Canton, Ohio 44710
Phone: 330-454-8076
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
Phone: 434-982-1058
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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Cincinnati, Ohio 45219
Phone: 513-585-1777
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Clearwater, Florida 33756
Phone: 727-467-9393
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Danville, Pennsylvania 17882
Phone: 570-271-7176
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Des Moines, Iowa 50314
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Doylestown, Pennsylvania 18901
Phone: 215-345-2842
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Duluth, Minnesota 55805
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Elyria, Ohio 44035
Phone: 440-366-2287
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3555 South Val Vista Drive
Gilbert, Arizona 85297
Phone: 602-214-0886
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Haddon Heights, New Jersey 08035
Phone: 856-757-0502
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Indianapolis, Indiana 46290
Phone: 317-583-6303
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Indianapolis, Indiana 46202
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3535 Southern Blvd
Kettering, Ohio 45429
(937) 298-4331
Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
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Los Angeles, California 90048
Phone: 424-415-4467
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4950 Norton Healthcare Boulevard
Louisville, Kentucky 40241
Phone: 502-446-8163
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New Haven, Connecticut 6520
(203) 432-4771
Yale University Yale's roots can be traced back to the 1640s, when colonial clergymen led...
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Ocala, Florida 34471
Phone: 352-351-7337
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8141 West Center Road
Omaha, Nebraska 68124
Phone: 402-343-8511
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Panama City, Florida 32401
Phone: 850-769-0329
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Petoskey, Michigan 49770
Principal Investigator: Louis Cannon, MD
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Raleigh, North Carolina 27610
Phone: 919-784-7695
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Royal Oak, Michigan 48073
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Tampa, Florida 33613
Phone: 813-615-7200
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Toledo, Ohio
Phone: 419-251-4919
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Tupelo, Mississippi 38801
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Tyler, Texas 75701
Phone: 903-510-7297
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110 Irving Street Northwest
Washington, District of Columbia 20010
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Winchester, Virginia 22604
Phone: 540-536-8978
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Wyomissing, Pennsylvania 19610
Phone: 610-685-4843
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2951 Maple Avenue
Zanesville, Ohio 43701
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