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

Tracking Information
First Submitted Date ICMJE	June 3, 2009
First Posted Date ICMJE	June 5, 2009
Last Update Posted Date	April 19, 2010
Study Start Date ICMJE	June 2009
Estimated Primary Completion Date	November 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: June 4, 2009)	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 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00914420 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: June 4, 2009)	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 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Optical Coherence Tomography (OCT) Evaluation of Re-endothelization: A Comparison of the Intrepide™ Stent Versus Taxus™
Official Title ICMJE	OCT Evaluation of Stent Struts Re-endothelization in Patients With Acute Coronary Syndromes: a Comparison of the Intrepide™ Stent vs. Taxus™
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
Detailed Description	Not Provided
Study Type ICMJE	Interventional
Study Phase	Phase 4
Study Design ICMJE	Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Treatment
Condition ICMJE	Coronary Artery Disease; Acute Coronary Syndrome
Intervention ICMJE	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.; Device: Taxus drug eluting stent Paclitaxel Drug eluting stent manufactured by Boston Scientific
Study Arms	Experimental: Intrepide Group A- Primary stenting with Intrepide trapidil eluting stent Intervention: Device: Intrepide Trapidil eluting stent; Experimental: Taxus Group B Stenting with Taxus DES Intervention: Device: Taxus drug eluting stent
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: June 4, 2009)	40
Original Estimated Enrollment ICMJE	Same as current
Estimated Study Completion Date	October 2012
Estimated Primary Completion Date	November 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Italy
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00914420
Other Study ID Numbers ICMJE	CST10
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Dr Giuseppe Sangiorgi Dr Antonio Colombo, University Hospital Modena - Italy ; Raffaele hospital, Milano- Italy
Study Sponsor ICMJE	Clearstream Technologies Ltd.
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Antonio Columbo, MD San Raffaele hospital, Milano Principal Investigator: Giuseppe M Sangiorgi, MD University Hospital Modena Italy
PRS Account	Clearstream Technologies Ltd.
Verification Date	April 2010
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP