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

NCT ID: NCT00914420

Last Updated: 2010-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2012-10-31

Brief Summary

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

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intrepide

Group A- Primary stenting with Intrepide trapidil eluting stent

Group Type: EXPERIMENTAL

Intrepide Trapidil eluting stent

Intervention Type: DEVICE

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.

Taxus

Group B Stenting with Taxus DES

Group Type: EXPERIMENTAL

Taxus drug eluting stent

Intervention Type: DEVICE

Paclitaxel Drug eluting stent manufactured by Boston Scientific

Interventions

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.

Intervention Type: DEVICE

Taxus drug eluting stent

Paclitaxel Drug eluting stent manufactured by Boston Scientific

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clearstream Technologies Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

University Hospital Modena - Italy ; Raffaele hospital, Milano- Italy

Principal Investigators

Antonio Columbo, MD

Role: PRINCIPAL_INVESTIGATOR

San Raffaele hospital, Milano

Giuseppe M Sangiorgi, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Modena Italy

Locations

University Hospital Modena

Modena, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Giuseppe M Sangiorgi, MD

Role: primary

sangiorgi.giuseppe@policlinico.mo.it

Related Links

http://www.clearstream.ie

Industry Sponsor

Other Identifiers

CST10

Identifier Type: -

Identifier Source: org_study_id