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| Name | Class |
|---|---|
| MEDRAD, Inc. | INDUSTRY |
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The DEFINITIVE AR study is a prospective, multi-center, randomized pilot study evaluating the use of either the TurboHawk™ or SilverHawk® plaque excision systems followed by treatment with the Cotavance™ drug-eluting balloon catheter versus the Cotavance balloon catheter alone in patients with peripheral arterial disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug-eluting balloon | Experimental | Subjects are randomized to have a lesion treated with a paclitaxel-coated balloon Intervention: Cotavance Drug-Eluting Balloon |
|
| Plaque excision + drug-eluting balloon | Experimental | Subjects are randomized to have a lesion treated with plaque excision (PE) followed by treatment with a paclitaxel-coated balloon Intervention: SilverHawk/TurboHawk + Cotavance Drug-Eluting Balloon |
|
| Severely Ca++ Group | Experimental | Subjects with a severely calcified lesion will be assigned to a non-randomized arm and treated with plaque excision followed by a drug-eluting balloon Intervention: SilverHawk/TurboHawk + Cotavance Drug-Eluting Balloon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cotavance Drug-Eluting Balloon | Device | Treatment with a paclitaxel-coated angioplasty balloon (without preceding plaque excision) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target Lesion Percent Stenosis | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Professor Thomas Zeller | Herz-Zentrum Bad Krozingen Germany | Principal Investigator |
| Professor Gunnar Tepe | Klinikum Rosenheim Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imelda Hospital | Bonheiden | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28916599 | Derived | Zeller T, Langhoff R, Rocha-Singh KJ, Jaff MR, Blessing E, Amann-Vesti B, Krzanowski M, Peeters P, Scheinert D, Torsello G, Sixt S, Tepe G; DEFINITIVE AR Investigators. Directional Atherectomy Followed by a Paclitaxel-Coated Balloon to Inhibit Restenosis and Maintain Vessel Patency: Twelve-Month Results of the DEFINITIVE AR Study. Circ Cardiovasc Interv. 2017 Sep;10(9):e004848. doi: 10.1161/CIRCINTERVENTIONS.116.004848. |
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| TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon | Device | Plaque excision with a SilverHawk or TurboHawk plaque excision device followed by treatment with a paclitaxel-coated angioplasty balloon |
|
| TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon | Device | Plaque excision followed by treatment with a paclitaxel-coated angioplasty balloon |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| D007383 | Intermittent Claudication |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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