Acute Coronary Syndrome, Coronary Artery Disease
Conditions
Keywords
OCT, Reendothelialisation, Intrepide, Trapidil, Taxus
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
Interventions
DEVICEIntrepide 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.
DEVICETaxus drug eluting stent
Paclitaxel Drug eluting stent manufactured by Boston Scientific
Sponsors
Clearstream Technologies Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Italy
Outcome results
None listed