A Prospective, Multi-centre, Single Treatment Clinical Trial With Follow-up Investigations at 1, 4, 9, 12, 24 and 36 Months

Biotronik AG2 sites in 1 country30 target enrollmentJuly 2009

ConditionsCoronary Artery Disease

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: Biotronik AG
Enrollment: 30
Locations: 2
Primary Endpoint: In-stent Late Lumen Loss
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2009

End Date

July 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biotronik AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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;

Outcomes

Primary Outcomes

In-stent Late Lumen Loss

Time Frame: 9 months post procedure

Secondary Outcomes

In-stent and in-segment (proximal and distal) minimum lumen diameter(4 and 9 months post-procedure)
In-stent and in-segment binary restenosis rate(4 and 9 months post procedure.)
In-segment late lumen loss(4 and 9 months post procedure)
In-stent late lumen loss(4 months post procedure.)
Target Lesion Revascularization(1, 4 and 9 months and at 1, 2 and 3 years post-procedure)
Clinically driven target lesion revascularization(1, 4 and 9 months and at 1, 2 and 3 years post-procedure)
Target Vessel Revascularization(1, 4 and 9 months and at 1, 2 and 3 years post-procedure)
- Composite of cardiac death, MI attributed to the target vessel and clinically driven target lesion revascularization(1, 4 and 9 month post-procedure, and yearly up to 3 years)
- Composite of all-cause mortality, any MI and any revascularization, target vessel revascularization or revascularization of nontarget vessels(3 years post procedure)
Stent thrombosis(1, 4 and 9 months and 1, 2 and 3 years post-procedure)
Neointimal hyperplasia volume (subgroup)(4 and 9 months post-procedure measured by Intravascular Ultrasound (IVUS))