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
  Purpose

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 Intervention Phase
Coronary Artery Disease
Acute Coronary Syndrome
Device: Intrepide Trapidil eluting stent
Device: Taxus drug eluting stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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™

Resource links provided by NLM:


Further study details as provided by Clearstream Technologies Ltd.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
Study Start Date: June 2009
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914420

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:
No publications provided

Responsible Party: Dr Giuseppe Sangiorgi Dr Antonio Colombo, University Hospital Modena - Italy ; Raffaele hospital, Milano- Italy
ClinicalTrials.gov Identifier: NCT00914420     History of Changes
Other Study ID Numbers: CST10
Study First Received: June 3, 2009
Last Updated: April 16, 2010
Health Authority: Italy: Ministry of Health

Keywords provided by Clearstream Technologies Ltd.:
OCT
Reendothelialisation
Intrepide
Trapidil
Taxus

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Trapidil
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasodilator Agents
Cardiovascular Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 29, 2014