Optical Coherence Tomography (OCT) Evaluation of Re-endothelization: A Comparison of the Intrepide™ Stent Versus Taxus™ (OISTER)
|ClinicalTrials.gov Identifier: NCT00914420|
Recruitment Status : Unknown
Verified April 2010 by Clearstream Technologies Ltd..
Recruitment status was: Recruiting
First Posted : June 5, 2009
Last Update Posted : April 19, 2010
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|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|
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.
Group B Stenting with Taxus DES
Device: Taxus drug eluting stent
Paclitaxel Drug eluting stent manufactured by Boston Scientific
- 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 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00914420
|University Hospital Modena||Recruiting|
|Contact: Giuseppe M Sangiorgi, MD firstname.lastname@example.org|
|Principal Investigator: Giuseppe Sangiorgi, MD|
|Principal Investigator:||Antonio Columbo, MD||San Raffaele hospital, Milano|
|Principal Investigator:||Giuseppe M Sangiorgi, MD||University Hospital Modena Italy|