Status:
TERMINATED
COronary Native Artery First in Man Investigation of ISA 247 Elution to Prevent Restenotic Mechanisms (CONFIRM 1)
Lead Sponsor:
Atrium Medical Corporation
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This First In Man study is a prospective, multicentre, single blind, randomized, controlled clinical trial of the CINATRA™ ISA 247 Coated Coronary Stent System as compared to the CINATRA™ Coronary Ste...
Eligibility Criteria
Inclusion
- Patients with stable angina pectoris (Canadian Cardiovascular Society 1, 2, 3) or unstable angina pectoris with documented ischemia (CCS 4, Braunwald Class IB-C, IIB-C or IIIB-C), or patients with documented silent ischemia.
- Patients who are eligible for coronary revascularization (percutanous angioplasty).
- Acceptable candidates for coronary artery bypass grafting (CABG).
- Patients with de novo lesion in a native coronary artery \>50% and \<100% stenosis.
- NOTE: Treatment of lesions in a non-target vessel is up to the investigator's discretion (max. two-vessel-disease).
- ONLY a bare metal stent (no drug eluting stent) can be used for this treatment. Treatment of any non-target vessel lesions must be successfully completed before enrolling patient and placing study stent.
- The target lesion must be a maximum length of 13 mm (visual estimate) and able to be covered by one stent.
- The reference diameter of the target lesion must be 3.0 mm by visual estimate.
- Left ventricular ejection fraction of \>30%.
- Patients willing to provide written informed consent prior to participation and willing and able to participate in all follow-up evaluations.
Exclusion
- Patients under the age of 18 or unable to give informed consent.
- Women who are pregnant. Women of child bearing potential must have a negative pregnancy test within 7 days prior to enrollment and utilize reliable contraception at a minimum until after the angiographic follow up.
- Patients who previously participated in this study.
- Patient is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
- NOTE: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
- Life expectancy of less than 12 months or factors making clinical and/or angiographic follow-up difficult (no fixed address, etc.).
- Patients who intend to have a major surgical intervention within 6 months of enrollment in the study.
- Patients with new ST elevation within 48 hours prior to stenting.
- Braunwald Class IA, IIA and IIIA angina pectoris.
- Patients with a contraindication to an emergency coronary bypass surgery.
- Patients who had previous Coronary Artery Bypass Surgery (CABG).
- Any individual who may refuse a blood transfusion.
- Serum creatinine \>3.0 mg/dL.
- Platelet count \<100,000 cells/mm³.
- Patients with intolerance or contraindication to acetylsalicylic acid (aspirin), heparin, cyclosporin or cyclosporine derivative, clopidogrel or ticlopidine drug therapy.
- Patients with contrast agent hypersensitivity that cannot be adequately pre-medicated.
- Patients who have a stent anywhere within the target vessel.
- Any planned interventional treatment of any vessel post study procedure.
- Exclusion Criteria Related to Angiography
- Patients with previous PCI of the same segment (i.e. no restenotic lesions).
- Previous interventional procedure (less than 6 months) anywhere within the target vessel;
- Target lesion is located in or supplied by an arterial or venous bypass graft.
- Target lesion involves a side branch \>2.0mm in diameter.
- Ostial target lesion (within 3.0mm of vessel origin).
- Target vessel has evidence of thrombus or is excessively tortuous that makes it unsuitable for proper stent delivery and deployment .
- Patients with total occlusions (TIMI 0).
- Significant (\>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off.
- Target lesion requires treatment with a device other than the predilatation balloon prior to stent placement (including but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, cutting balloon etc.).
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT00689767
Start Date
June 1 2008
End Date
July 1 2012
Last Update
April 17 2013
Active Locations (7)
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1
Middelheim Hospital
Antwerp, Belgium
2
Imelda ziekenhuis
Bonheiden, Belgium, 2820
3
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
4
Ziekenhuis Oost Limburg, Campus Sint Jan
Genk, Belgium, 3600