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

Coronary Artery Disease Clinical Trial

— OISTER  

Official title:

OCT Evaluation of Stent Struts Re-endothelization in Patients With Acute Coronary Syndromes: a Comparison of the Intrepide™ Stent vs. Taxus™

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00914420
• Other study ID #: CST10
• Status: Recruiting
• Phase: Phase 4
• First received: June 3, 2009
• Last updated: April 16, 2010
• Start date: June 2009
• Est. completion date: October 2012

Study information

• Verified date: April 2010
• Source: Clearstream Technologies Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2012
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.
• Taxus drug eluting stent
Paclitaxel Drug eluting stent manufactured by Boston Scientific

Locations

Country	Name	City	State
Italy	University Hospital Modena	Modena

Sponsors (1)

Lead Sponsor	Collaborator
Clearstream Technologies Ltd.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes

External Links

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