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

NCT ID: NCT01214148

Last Updated: 2013-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ORSIRO

Group Type OTHER

ORSIRO - Drug Eluting Coronary Stent

Intervention Type 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.

Interventions

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ORSIRO - Drug Eluting Coronary Stent

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.

Intervention Type DEVICE

Eligibility Criteria

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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%);
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biotronik AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martial Hamon, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Caen

Locations

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

Bucharest, , Romania

Site Status

Spitalul Clinic de Urgenţă Bucureşti

Bucharest, , Romania

Site Status

Countries

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Romania

Other Identifiers

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C0904

Identifier Type: -

Identifier Source: org_study_id