Status:
COMPLETED
A Clinical Evaluation of the ProNOVA XR Polymer Free Drug Eluting Coronary Stent System
Lead Sponsor:
KCRI
Collaborating Sponsors:
Vascular Concepts Limited
Conditions:
Myocardial Ischemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
The objective of this study is the assessment of the performance, safety and efficacy of the ProNOVA XR Polymer Free Drug Eluting Stent System in the treatment of patients with de novo native coronary...
Detailed Description
This study is a prospective, single arm, multicenter registry of approximately 50 patients undergoing PCI with the ProNOVA Drug Eluting Coronary Stent System according to its Instructions for Use. Th...
Eligibility Criteria
Inclusion
- General
- Patient must be at least 18 years of age.
- Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the ProNOVA XR DES and she or her legally authorized representative provides written informed consent prior to any study related procedure, as approved by the appropriate Medical Ethics Committee of the respective clinical site.
- Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or a reversible change in the electrocardiogram (ECG) consistent with ischemia)
- Patient must agree to undergo all required follow-up examinations.
- Patients of childbearing potential must have had a negative pregnancy test within 7 days before treatment, and must not be nursing at the time of treatment.
- Angiographic
- Target lesions must be de novo lesions (no prior stent implant, no prior brachytherapy)
- Target vessel reference diameter must be between 2.25 mm and 4.0 mm by visual estimate
- Target lesion ≤ 28 mm in length by visual estimate
Exclusion
- Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical investigation plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year)
- Patient has a known hypersensitivity or contraindication to aspirin, either heparin or bivalirudin, both clopidogrel and ticlopidine, cobalt, chromium, nickel, or contrast sensitivity that cannot be adequately pre-medicated
- Participation in another device or drug study or has completed the follow-up phase of another study within the last 30 days
- Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01151033
Start Date
November 1 2008
End Date
September 1 2010
Last Update
January 20 2011
Active Locations (3)
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1
Department of Haemodynamics and Angiocardiography Medical College Jagiellonian University University Hospital in Krakow
Krakow, Poland
2
Oddział Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Sacz
Nowy Sącz, Poland
3
Oddział Kardiologii Inwazyjnej Elektroterapii i Angiologii NZOZ Nowy Targ
Nowy Targ, Poland