Status:
UNKNOWN
Numen Stent Assessment Using OCT Technique in a Single Center Study
Lead Sponsor:
International Biomedical Systems S.p.A.
Collaborating Sponsors:
CSC Pharmaceuticals
Conditions:
Hyperplasia
Restenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
This is a prospective single centre Study designed to assess by OCT the effect of NUMEN cobalt-chromium balloon-expandable stent in inducing neointimal hyperplasia in de novo native coronary lesions o...
Detailed Description
OBJECTIVES The main objective of this study is to assess the long term influence of NUMEN cobalt-chromium balloon-expandable coronary stent on neointimal hyperplasia in de novo native coronary lesion...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- Patients must meet all of the following criteria:
- The patient must be \> 18 years of age;
- Diagnosis of stable angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) or ACS (except STEMI).
- Treatment of de novo lesion in a major coronary artery in patients with single or two-vessel disease.
- Target vessel diameter at the lesion site is \>2.50mm and \<3.50mm in diameter (QCA);
- Target lesion is \>10mm and \<24mm in length (visual estimate);
- Target lesion stenosis is \>50% and \<100% (visual estimate);
- Acceptable candidate for coronary artery bypass surgery (CABG);
- Patient is willing to comply with the specified follow-up evaluation;
- Patient must provide written informed consent prior to the procedure using a form that is approved by the local Ethics Committee.
- EXCLUSION CRITERIA
- Patients will be excluded if any of the following conditions apply:
- multiple lesions in the same vessel;
- ACS with STEMI (within 48 hours)
- vessel size \< 2.50mm and \>3.50mm reference diameter;
- length of the lesion \> 24 mm;
- unprotected left main coronary disease with \>50% stenosis;
- have an ostial target lesion;
- have a target lesion in a venous graft;
- angiographic evidence of thrombus within target lesion;
- calcified lesion which cannot be successfully predilated;
- Documented left ventricular ejection fraction \>25%;
- Impaired renal function (creatinine \> 3.0 mg/dl) at the time of treatment;
- Pretreatment with devices other than balloon angioplasty;
- Prior stent within 5mm of target lesion;
- Recipient of heart transplant;
- Known allergies to the following: aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, cobalt, chromium, or contrast agent (that cannot be managed medically)
- Recent (6 months) cerebrovascular accidents or intracranial hemorrage
- Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study;
- Currently participating in an investigational drug or another medical device study;
- In the investigator's opinion, the lesion is not suitable for stenting.
- Life expectancy ≤ 12 months
Exclusion
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00774917
Start Date
October 1 2008
End Date
March 1 2010
Last Update
June 23 2009
Active Locations (2)
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1
University Hospital of Vienna
Vienna (Austria), Vienna, Austria
2
SMZ-Ost Donauspital
Vienna, Austria