First in Man Experience With a Drug Eluting Stent in De Novo Coronary Artery Lesions

NCT01214148 | Completed Phase 1 DMC

• 1 other identifier: C0904
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• In-stent Late Lumen Loss

  9 months post procedure

Secondary Outcomes (11)

• In-stent and in-segment binary restenosis rate

  4 and 9 months post procedure.

• In-stent and in-segment (proximal and distal) minimum lumen diameter

  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

Study Arms (1)

ORSIRO

OTHER

Device: ORSIRO - Drug Eluting Coronary Stent

Interventions

ORSIRO - Drug Eluting Coronary Stent DEVICE

The coronary stent is delivered to the intended implantation location by means of the fast-exchange delivery system and then expanded to its final diameter by dilating the balloon. It remains in the vessel as a permanent implant.

ORSIRO

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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%);

Sponsors & Collaborators

• Biotronik AG: lead

Study Sites (2)

Institutul de Urgenţă pentru Boli Cardiovasculare "Prof. Dr. C. C. Iliescu" - Spitalul Clinic Fundeni

Bucharest, Romania

Location

Spitalul Clinic de Urgenţă Bucureşti

Bucharest, Romania

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Martial Hamon, MD

  Centre Hospitalier Universitaire Caen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 4, 2010
• Study Start: July 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: July 1, 2013
• Last Updated: August 12, 2013

Record last verified: 2013-08

Locations

RO (2)