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

• ClinicalTrials.gov Identifier: NCT00914420
• Recruitment Status: Unknown
• First Posted: June 5, 2009
• Last Update Posted: April 19, 2010
• Sponsor: Clearstream Technologies Ltd.
• Information provided by: Clearstream Technologies Ltd.

Study Description

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

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease; Acute Coronary Syndrome	Device: Intrepide Trapidil eluting stent; Device: Taxus drug eluting stent	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: OCT Evaluation of Stent Struts Re-endothelization in Patients With Acute Coronary Syndromes: a Comparison of the Intrepide™ Stent vs. Taxus™
• Study Start Date: June 2009
• Estimated Primary Completion Date: November 2010
• Estimated Study Completion Date: October 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: 3 months ]

Secondary Outcome Measures :

1. In-stent binary angiographic restenosis and in-stent late lumen loss; in segment late loss; assessed by quantitative computed angiography (QCA) at 12 months [ Time Frame: 12 months ]

Eligibility Criteria

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

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

Contacts and Locations

Locations

Italy

University Hospital Modena; Recruiting

Modena, Italy

Contact: Giuseppe M Sangiorgi, MD sangiorgi.giuseppe@policlinico.mo.it

Principal Investigator: Giuseppe Sangiorgi, MD

Sponsors and Collaborators

Clearstream Technologies Ltd.

Investigators

• Principal Investigator: Antonio Columbo, MD; San Raffaele hospital, Milano
• Principal Investigator: Giuseppe M Sangiorgi, MD; University Hospital Modena Italy

More Information

Additional Information:

Industry Sponsor 

• Responsible Party: Dr Giuseppe Sangiorgi Dr Antonio Colombo, University Hospital Modena - Italy ; Raffaele hospital, Milano- Italy
• ClinicalTrials.gov Identifier: NCT00914420
• Other Study ID Numbers: CST10
• First Posted: June 5, 2009
• Last Update Posted: April 19, 2010
• Last Verified: April 2010

Keywords provided by Clearstream Technologies Ltd.:

OCT; Reendothelialisation; Intrepide; Trapidil; Taxus

Additional relevant MeSH terms:

Coronary Artery Disease; Acute Coronary Syndrome; Syndrome; Disease; Pathologic Processes; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Trapidil; Phosphodiesterase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Vasodilator Agents