First in Man Experience With a Drug Eluting Stent in De Novo Coronary Artery Lesions (BIOFLOW-I)

Biotronik

Status and phase: Completed; Phase 2; Phase 1

Conditions: Coronary Artery Disease

Treatments: Device: ORSIRO - Drug Eluting Coronary Stent

Study type: Interventional

Funder types: Industry

Identifiers

NCT01214148

C0904

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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%);

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

ORSIRO

Other group

Treatment:

Device: ORSIRO - Drug Eluting Coronary Stent