Optical Coherence Tomography (OCT) Evaluation of Re-endothelization: A Comparison of the Intrepide™ Stent Versus Taxus™ (OISTER)

OCT Evaluation of Stent Struts Re-endothelization in Patients With Acute Coronary Syndromes: a Comparison of the Intrepide™ Stent vs. Taxus™

Patients presenting with ACS (Acute Coronary Syndrome) in the emergency department will be screened for clinical eligibility and asked to sign informed consent to the study.

A total of 40 patients will be randomized. 20 of them will receive a Trapidil eluting stent (Intrepide™ stent), 20 will receive a Paclitaxel eluting stent (Taxus™ stent). After 90 days the patients who were treated with the INTREPIDE stent in the first lesion will be treated with the Taxus stent in the second lesion. After 90 days the patients who were treated with the Taxus stent in the first lesion will be treated with the INTREPIDE stent in the second lesion.

Coronary angiography will be performed through the femoral (groin) or radial (wrist) artery with the use of standard techniques. The doctor will determine if the patient is qualified for enrolment at the end of the diagnostic coronary angiogram

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Acute Coronary Syndrome
• Intervention / Treatment: Device: Intrepide Trapidil eluting stent; Device: Taxus drug eluting stent

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Modena, Italy
    • Recruiting
    • University Hospital Modena
    • Contact: Giuseppe M Sangiorgi, MD; Email: sangiorgi.giuseppe@policlinico.mo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Clinical

• >18 years of age,
• symptoms of non ST-elevation ACS (defined by the ACC/AHA criteria) for 30 min but <48 h
• Patient must provide written informed consent prior to the procedure using a form that is approved by the local Institutional Review Board

Angiographic

• reference vessel diameter of culprit/target lesion between 2.25 to 3.5 mm (visual estimate)
• discrete target lesion (maximum length of 28 mm by visual estimation)
• target lesion is in a native coronary artery
• presence of another lesion more than 70% in a vessel different from the culprit one amenable of planned percutaneous treatment 90 days thereafter.

Exclusion Criteria:

Clinical

• previously documented left ventricular ejection fraction of less than 30%
• estimated life expectancy of less than 12 months
• a history of bleeding diathesis, leukopenia, thrombocytopenia, or severe hepatic or renal dysfunction
• participation in another study
• inability to give informed consent owing to prolonged cardiopulmonary resuscitation
• and dominant Renal impairment (serum creatinine > 2.0 mg/dl) Angiographic
• non-culprit lesion located in the proximal LAD or in a proximal and dominant Circumflex artery
• previous PCI of the target vessels restenosis or stent thrombosis as culprit lesion
• unprotected left main coronary artery disease
• non-culprit lesion located in a vein graft
• severe multivessel disease (three major epicardial vessel disease) need of overlapping stenting for one lesion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intrepide; Group A- Primary stenting with Intrepide trapidil eluting stent	Device: Intrepide Trapidil eluting stent; The INTREPIDE coronary stent system consists of a balloon expandable stent coated with two layers of Trapidil and parylene. The Trapidil eluting stent is pre-mounted on a Nimbus PCTA balloon and is intended for use in the treatment of CAD. The controlled release of Trapidil is achieved through the parylene barrier, locally delivering the drug to the target lesion, inhibiting smooth muscle cell proliferation and hence neointimal hyperplasia.
Experimental: Taxus; Group B Stenting with Taxus DES	Device: Taxus drug eluting stent; Paclitaxel Drug eluting stent manufactured by Boston Scientific

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To compare stent re-endothelialization using Trapidil drug eluting stent versus Taxus paclitaxel eluting stent at 3 months after intervention. The primary endpoint will be defined by % of stent struts neointimal coverage at 90 days	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
In-stent binary angiographic restenosis and in-stent late lumen loss; in segment late loss; assessed by quantitative computed angiography (QCA) at 12 months	12 months

Collaborators and Investigators

• Sponsor: Clearstream Technologies Ltd.
• Investigators: Principal Investigator: Antonio Columbo, MD, San Raffaele Hospital, Milano; Principal Investigator: Giuseppe M Sangiorgi, MD, University Hospital Modena Italy

Publications and helpful links

Helpful Links

• Industry Sponsor

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Anticipated): November 1, 2010
• Study Completion (Anticipated): October 1, 2012

Study Registration Dates

• First Submitted: June 3, 2009
• First Submitted That Met QC Criteria: June 4, 2009
• First Posted (Estimate): June 5, 2009

Study Record Updates

• Last Update Posted (Estimate): April 19, 2010
• Last Update Submitted That Met QC Criteria: April 16, 2010
• Last Verified: April 1, 2010

More Information

Terms related to this study

• Keywords: OCT; Reendothelialisation; Intrepide; Trapidil; Taxus
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease; Coronary Disease; Coronary Artery Disease; Syndrome; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Phosphodiesterase Inhibitors; Trapidil
• Other Study ID Numbers: CST10