Clinical trial NCT00914420: Optical Coherence Tomography (OCT) Evaluation of Re-endothelization: A Comparison of the Intrepide™ Stent Versus Taxus™
Official title: OCT Evaluation of Stent Struts Re-endothelization in Patients With Acute Coronary Syndromes: a Comparison of the Intrepide™ Stent vs. Taxus™
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Acute Coronary Syndrome
Keywords: OCT
Reendothelialisation
Intrepide
Trapidil
Taxus
Lead sponsor: Clearstream Technologies Ltd.
Sponsor class: INDUSTRY
First posted: 2009-06-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
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
timeFrame: 3 months
Secondary outcomes:
measure: In-stent binary angiographic restenosis and in-stent late lumen loss; in segment late loss; assessed by quantitative computed angiography (QCA) at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Modena
country: Italy
facility: University Hospital Modena
Study officials:
affiliation: San Raffaele hospital, Milano
name: Antonio Columbo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Modena Italy
name: Giuseppe M Sangiorgi, MD
role: PRINCIPAL_INVESTIGATOR
References: