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The purpose of the artery preparation concept is to perform regular longitudinal micro-incisions on the inner side of the artery ("scoring") and therefore promote a regular expansion of atheroma by balloon inflation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FLEX Scoring Catheter plus DEB | Experimental | The target lesion is prepared by the FLEX Scoring Catheter® with a 30° rotation between each passage. Angioplasty is performed during 3 minutes with paclitaxel-coated balloon(s) (PCB), all along the target lesion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FLEX Scoring Catheter | Device | Vessel preparation with the FLEX Scoring Catheter® with a 30° rotation between each passage is performed, followed by a DEB angioplasty. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Absence of clinically driven target lesion revascularization (CDTLR) at 12 months | 12 months | |
| Occurrence of death from cardiovascular origin | 12 months | |
| Occurrence of major amputation of target limb | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Primary patency of the treated lesion (defined by PSVR ≤ 2.5 at duplex scan) | 3 and 12 months | |
| Absence of CDTLR | 3 months | |
| Absence of major amputation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Periard, MD | Fribourg Cantonal Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Cantonal de Fribourg | Fribourg | Switzerland |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| 3 and 12 months |
| Change in ankle brachial index (ABI) | 3 and 12 months |
| Change in Rutherford class of symptom | 3 and 12 Months |
| Technical success of the scoring procedure | Average of 2 hours |
| Proportion of luminal gain | Average of 2 hours |
| Occurrence of dissection | Average of 2 hours |
| Proportion of stent implantation | Average of 2 hours |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |