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

NCT00914420 | Unknown Phase 4 DMC

• 1 other identifier: CST10
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Keywords

OCT; Reendothelialisation; Intrepide; Trapidil; Taxus

Outcome Measures

Primary Outcomes (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

  3 months

Secondary Outcomes (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

  12 months

Study Arms (2)

Intrepide

EXPERIMENTAL

Group A- Primary stenting with Intrepide trapidil eluting stent

Device: Intrepide Trapidil eluting stent

Taxus

EXPERIMENTAL

Group B Stenting with Taxus DES

Device: Taxus drug eluting stent

Interventions

Intrepide Trapidil eluting stent DEVICE

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.

Intrepide

Taxus drug eluting stent DEVICE

Paclitaxel Drug eluting stent manufactured by Boston Scientific

Taxus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Clearstream Technologies Ltd.: lead

Study Sites (1)

University Hospital Modena

Modena, Italy

RECRUITING

Related Links

• Industry Sponsor

MeSH Terms

Conditions

Coronary Artery Disease; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Antonio Columbo, MD

  San Raffaele hospital, Milano

  PRINCIPAL INVESTIGATOR

• Giuseppe M Sangiorgi, MD

  University Hospital Modena Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 5, 2009
• Study Start: June 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: October 1, 2012
• Last Updated: April 19, 2010

Record last verified: 2010-04

Locations

IT (1)