Clinical trial NCT01214148: First in Man Experience With a Drug Eluting Stent in De Novo Coronary Artery Lesions
Official title: A Prospective, Multi-centre, Single Treatment Clinical Trial With Follow-up Investigations at 1, 4, 9, 12, 24 and 36 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Coronary Artery Disease
Lead sponsor: Biotronik AG
Sponsor class: INDUSTRY
First posted: 2010-10-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 endpoint of late lumen loss and secondary endpoints. A subgroup of 15 patients will also undergo post implantation, 4 and 9 months IVUS examinations. Additional clinical follow-ups take place at 1 month and yearly up to three (3) years.

The objective of this trial is to assess the safety and clinical performance of the ORSIRO drug eluting stent in patients with single de-novo coronary artery lesions.


Eligibility criteria: Inclusion Criteria:

1. Patient is ≥18 years old;
2. 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;
3. Single de novo lesion with ≥50% and \<90% stenosis in 1 coronary artery;

Exclusion Criteria:

1. Documented left ventricular ejection fraction (LVEF) ≤30%;
2. Unstable angina pectoris(Braunwald Class A I-III)
3. Three-vessel coronary artery disease
4. Evidence of myocardial infarction within 72 hours prior to the index procedure;
5. 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)
6. A platelet count \<100.000 cells/mm3 or \>700.000 cells/mm3 or a WBC \<3.000 cells/mm3;
7. Acute or chronic renal dysfunction (serum creatinine \>2.0 mg/dl or \>150µmol/L);
8. Total occlusion (TIMI 0 or 1);
9. Target vessel has evidence of thrombus or is excessively tortuous that makes it unsuitable for proper stent delivery and deployment;
10. Significant (\>50%) stenosis proximal or distal to the target lesion that might require revascularization or impede run off;
11. Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated;
12. Target lesion is located in or supplied by an arterial or venous bypass graft;
13. Ostial target lesion (within 5.0mm of vessel origin);
14. Target lesion involves a side branch \>2.0mm in diameter;
15. Unprotected Left main coronary artery disease (stenosis \>50%);

Primary outcomes:
measure: In-stent Late Lumen Loss
timeFrame: 9 months post procedure
Secondary outcomes:
measure: In-stent and in-segment binary restenosis rate
timeFrame: 4 and 9 months post procedure.
measure: In-stent and in-segment (proximal and distal) minimum lumen diameter
timeFrame: 4 and 9 months post-procedure
measure: In-segment late lumen loss
timeFrame: 4 and 9 months post procedure
measure: In-stent late lumen loss
timeFrame: 4 months post procedure.
measure: Target Lesion Revascularization
timeFrame: 1, 4 and 9 months and at 1, 2 and 3 years post-procedure
measure: Clinically driven target lesion revascularization
timeFrame: 1, 4 and 9 months and at 1, 2 and 3 years post-procedure
measure: Target Vessel Revascularization
timeFrame: 1, 4 and 9 months and at 1, 2 and 3 years post-procedure
measure: - Composite of cardiac death, MI attributed to the target vessel and clinically driven target lesion revascularization
timeFrame: 1, 4 and 9 month post-procedure, and yearly up to 3 years
measure: - Composite of all-cause mortality, any MI and any revascularization, target vessel revascularization or revascularization of nontarget vessels
timeFrame: 3 years post procedure
measure: Stent thrombosis
timeFrame: 1, 4 and 9 months and 1, 2 and 3 years post-procedure
measure: Neointimal hyperplasia volume (subgroup)
timeFrame: 4 and 9 months post-procedure measured by Intravascular Ultrasound (IVUS)
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Institutul de Urgenţă pentru Boli Cardiovasculare "Prof. Dr. C. C. Iliescu" - Spitalul Clinic Fundeni
city: Bucharest
country: Romania
facility: Spitalul Clinic de Urgenţă Bucureşti
Study officials:
affiliation: Centre Hospitalier Universitaire Caen
name: Martial Hamon, MD
role: PRINCIPAL_INVESTIGATOR
References: