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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Clearstream Technologies Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Clearstream Technologies Ltd.
ClinicalTrials.gov Identifier:
NCT00914420
First received: June 3, 2009
Last updated: April 16, 2010
Last verified: April 2010

June 3, 2009
April 16, 2010
June 2009
November 2010   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00914420 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Optical Coherence Tomography (OCT) Evaluation of Re-endothelization: A Comparison of the Intrepide™ Stent Versus Taxus™
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

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Coronary Artery Disease
  • Acute Coronary Syndrome
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
October 2012
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
Italy
 
NCT00914420
CST10
Yes
Dr Giuseppe Sangiorgi Dr Antonio Colombo, University Hospital Modena - Italy ; Raffaele hospital, Milano- Italy
Clearstream Technologies Ltd.
Not Provided
Principal Investigator: Antonio Columbo, MD San Raffaele hospital, Milano
Principal Investigator: Giuseppe M Sangiorgi, MD University Hospital Modena Italy
Clearstream Technologies Ltd.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP