Status:
COMPLETED
First in Man Experience With a Drug Eluting Stent in De Novo Coronary Artery Lesions
Lead Sponsor:
Biotronik AG
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief Summary
A prospective, single-treatment, multi centre clinical trial enrolling 30 patients in 2 centres in Romania, with a clinical and angiographic follow-up at 4 and 9 months to determine the primary endpoi...
Eligibility Criteria
Inclusion
- Patient is ≥18 years old;
- Clinical evidence of ischemic heart disease and / or a positive functional study. Documented stable angina pectoris (Canadian cardiovascular society classification (CCS) 1, 2, 3 or 4 ), or documented silent ischemia;
- Single de novo lesion with ≥50% and \<90% stenosis in 1 coronary artery;
Exclusion
- Documented left ventricular ejection fraction (LVEF) ≤30%;
- Unstable angina pectoris(Braunwald Class A I-III)
- Three-vessel coronary artery disease
- Evidence of myocardial infarction within 72 hours prior to the index procedure;
- Known allergies to the following: Acetylsalicylic acid (ASA) (Aspirin®), Clopidogrel bisulfate (Plavix®.) or Ticlopidine (Ticlid®.), Heparin, contrast agent (that cannot be adequately premedicated), cobalt-chromium (CoCr), Poly-L-Lactidic Acid (PLLA), silicon carbide (aSiC:H)
- A platelet count \<100.000 cells/mm3 or \>700.000 cells/mm3 or a WBC \<3.000 cells/mm3;
- Acute or chronic renal dysfunction (serum creatinine \>2.0 mg/dl or \>150µmol/L);
- Total occlusion (TIMI 0 or 1);
- Target vessel has evidence of thrombus or is excessively tortuous that makes it unsuitable for proper stent delivery and deployment;
- Significant (\>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off;
- Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated;
- Target lesion is located in or supplied by an arterial or venous bypass graft;
- Ostial target lesion (within 5.0mm of vessel origin);
- Target lesion involves a side branch \>2.0mm in diameter;
- Unprotected Left main coronary artery disease (stenosis \>50%);
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01214148
Start Date
July 1 2009
End Date
July 1 2013
Last Update
August 12 2013
Active Locations (2)
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1
Institutul de Urgenţă pentru Boli Cardiovasculare "Prof. Dr. C. C. Iliescu" - Spitalul Clinic Fundeni
Bucharest, Romania
2
Spitalul Clinic de Urgenţă Bucureşti
Bucharest, Romania