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| Name | Class |
|---|---|
| CardioVascular Research Foundation, Korea | OTHER |
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This study is to establish the primary hypothesis that debulking with rotational atherectomy (RA) followed by balloon angioplasty (BA) is superior to BA alone for lesion preparation in patients with coronary in-stent restenosis (ISR) regarding angiography-measured in-segment minimal lumen area at 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rotational atherectomy followed by balloon angioplasty | Experimental |
| |
| balloon angioplasty | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotational atherectomy followed by balloon angioplasty | Procedure | Percutaneous coronary intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| In-segment minimal lumen diameter on angiographic | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Device success rate | 1 year | |
| Angiographic outcomes immediate after procedure | In-segment and in-stent minimal lumen diameter and diameter stenosis | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soon Chun Hyang University Hospital Bucheon | Bucheon-si | South Korea | ||||
| Chonnam National University Hospital |
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| ID | Term |
|---|---|
| D000800 | Angioplasty, Balloon |
| ID | Term |
|---|---|
| D017130 | Angioplasty |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
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| Balloon angioplasty | Procedure | Percutaneous coronary intervention |
|
| OCT outcomes immediate after procedure : In-segment and in-stent minimal lumen area | 1 hour |
| OCT outcomes immediate after procedure : In-segment and in-stent neointimal volume | 1 hour |
| Angiographic outcomes : In-segment and in-stent late loss, diameter stenosis | 1 year |
| OCT outcomes : in-segment and in-stent late lumen area, minimal lumen area loss | 1 year |
| composite event rate | A composite event of following factors is defined as the occurrence of any event from these events and denoted that event as the union of these.
| 1 year |
| Gwangju |
| South Korea |
| Asan Medical Center | Seoul | South Korea |
| D014656 |
| Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |