Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Interventional, prospective, non-randomized, non-comparative, open and multicentric study of patients with everolimus-eluting stent " Xience V® " implanted in the treatment of restenosis in non-coated metallic stent (BMS in-stent restenosis) during a 2 year clinical follow-up period.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xience V® | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xience V® | Device | Placement of a Xience V® stent within a restenosed bare metal stent. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation by QCA (Quantitative Coronary Angiography) of in-stent late loss after the implantation of the stent XIENCE V® | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation by IVUS (Intra Vascular Ultrasound) of the in-stent volume obstruction percentage (%VO) after the implantation of a XIENCE V® stent | 9 months | |
| Evaluation by IVUS of the mean volume of neointimal hyperplasia after the implantation of a XIENCE V® stent |
Not provided
Inclusion Criteria:
Angiographic inclusion criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Didier Carrie, MD | HOPITAL DE RANGUEIL - CHU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital de Rangueil - Chu | Toulouse | 31403 | France |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 9 months |
| Evaluation by QCA of the in-stent binary restenosis rate | 9 months |
| Evaluation of the in-segment binary restenosis rate | 9 months |
| Evaluation by QCA of in-segment late loss | 9 months |
| Evaluation by IVUS of the in-segment % volume obstruction after the implantation of the XIENCE V® stent | 9 months |
| Evaluation by IVUS of the rate of late incomplete apposition | 9 months |
| Document the number of confirmed stent thrombosis | 1, 8, 9, 12 and 24 months |
| -Document the number of confirmed revascularizations (TLR, TVR) | 1, 8, 9, 12 and 24 months |
| Document the rate of MACE | 1, 8, 9, 12 and 24 months |
| ID | Term |
|---|---|
| D023903 | Coronary Restenosis |
| D014652 | Vascular Diseases |
| D017202 | Myocardial Ischemia |
| D023921 | Coronary Stenosis |
| D003327 | Coronary Disease |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
Not provided
Not provided