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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 (Intrepideâ„¢ stent), 20 will receive a Paclitaxel eluting stent (Taxusâ„¢ 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrepide | Experimental | Group A- Primary stenting with Intrepide trapidil eluting stent |
|
| Taxus | Experimental | Group B Stenting with Taxus DES |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Clinical
Angiographic
Exclusion Criteria:
Clinical
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| Name | Affiliation | Role |
|---|---|---|
| Antonio Columbo, MD | San Raffaele hospital, Milano | Principal Investigator |
| Giuseppe M Sangiorgi, MD | University Hospital Modena Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Modena | Recruiting | Modena | Italy |
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| Label | URL |
|---|---|
| Industry Sponsor | View source |
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|
| Taxus drug eluting stent | Device | Paclitaxel Drug eluting stent manufactured by Boston Scientific |
|
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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