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
Not provided
The main objective of this study is to assess the safety and effectiveness of the Cypherâ„¢ sirolimus-eluting stent in reducing angiographic in-lesion late loss in patients with an in-stent restenotic native coronary artery lesion.
This is a multicenter (11 sites), non-randomized study. Patients who meet the eligibility criteria will be treated with the Cypherâ„¢ sirolimus-eluting stent. All patients will have a repeat angiography at six months post-procedure and will be additionally followed clinically at 1, 6 and 9 months and up to 3 years. The results of this study will be compared with the outcome of the GAMMA I / II as the historical control.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Cypherâ„¢ sirolimus-eluting stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drug-eluting stent | Device | PCI |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| angiographic in-lesion late loss | 6 months post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| in-stent mean percent diameter stenosis (%DS) | 6-months post-procedure | |
| i-stent late loss (LL) | 6 months post-procedure | |
| in-lesion binary restenosis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Franz-Josef Neumann, MD | Herz-zentrum Bad Krozingen | Principal Investigator |
| Walter Desmet, MD | K.U. Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| K.U. Leuven | Leuven | 3000 | Belgium | |||
| Herz-zentrum Bad Krozingen |
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D054855 | Drug-Eluting Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 6-months post-procedure |
| Target Vessel Revascularization (TVR) | 9-months post-procedure |
| Target Vessel Failure (TVF) defined as any revascularization of the index vessel or myocardial infarction or death that cannot be clearly attributed to a vessel other than the index vessel | 9 months post-procedure |
| Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization in-hospital | 1, 6, 9 months and, 2 and 3 years post-procedure |
| occurrence of bleeding | 1, 6, 9 months and, 2 and 3 years post-procedure |
| Bad Krozingen |
| 78189 |
| Germany |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |