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The purpose of this study is to determine whether the use of drug-eluting balloons is effective in the treatment of (re)stenosis in bypass vein grafts.
Drug-eluting devices have proved beneficial in the treatment of stenosis in native coronary and lower limb arteries. Stenosis and restenosis is a known problem in bypass vein grafts, and drug-eluting devices might be beneficial in this field as well.
In the procedure a conventional balloon is passed through the stenosis which is then dilated. After this patients are randomized before a second dilatation with either a conventional balloon or a drug-coated balloon.
The stenosis is evaluated preoperatively and followed up by means of ultrasound by a vascular technician. Follow-up will end at 12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug-eluting balloon | Experimental |
| |
| Conventional PTA | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional PTA | Device | After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a conventional balloon |
|
| Measure | Description | Time Frame |
|---|---|---|
| TLR (Target lesion revascularization) | Any reintervention to the same lesion. | 12 months |
| Graft occlusion | Occlusion of the bypass graft | 0-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Major amputation | Above or below knee amputation of the treated leg | 0-12 months |
| Death | 0-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Primary assisted patency | Patency of the graft after TLR | 0-12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maarit Venermo, M.D., Ph.D. | Helsinki University Hospital, Dept. of Vascular Surgery | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Helsinki University Hospital | Helsinki | 00029 | Finland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30092443 | Derived | Bjorkman P, Kokkonen T, Alback A, Venermo M. Drug-Coated versus Plain Balloon Angioplasty in Bypass Vein Grafts (the DRECOREST I-Study). Ann Vasc Surg. 2019 Feb;55:36-44. doi: 10.1016/j.avsg.2018.04.042. Epub 2018 Aug 6. |
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|
| Drug-eluting balloon | Device | After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a drug-eluting balloon |
|
|
| ID | Term |
|---|---|
| C564658 | Peripheral Arterial Occlusive Disease 1 |
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| ID | Term |
|---|---|
| D017130 | Angioplasty |
| D000800 | Angioplasty, Balloon |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |
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