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The objective of this study is to evaluate the performance of the In.Pact Admiral DEB for the treatment of popliteal lesions in comparison with literature results of stent treatment in popliteal lesions
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| InPact Admiral | Experimental | Patients treated with the InPact Admiral balloon for popliteal lesions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InPact Admiral DEB | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Patency at 12 months | defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 12 months. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | defined as the ability to cross and dilate the lesion and achieve residual angiographic stenosis no greater than 30%. | 1 day post-op |
| Primary Patency at 1 and 6-months | defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within the time of procedure and the given follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeroen Wauters | Contact | +32 52 25 28 22 | office@fmrp.be |
| Name | Affiliation | Role |
|---|---|---|
| Marc Bosiers, MD | Flanders Medical Research Program | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imelda Hospital | Recruiting | Bonheiden | Antwerp | 2820 | Belgium |
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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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| 1 and 6 months |
| Clinical success at 1, 6 and 12-months | defined as an improvement of Rutherford classification at 1-, 6- and 12-month follow-up of one class or more as compared to the pre-procedure Rutherford classification | 1, 6 and 12 months |
| Serious Adverse Events | defined as a clinical event that is fatal, life-threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization | up to 12 months |
| Survival rate | all-cause death ratio | up to 12 months |
| Target Lesion Revascularization | defined as a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5 mm proximal and distal to the treated lesion edge | up to 12 months |
| Limb Salvage Rate | defined as absence of major amputation. Major amputation is defined as amputation at or above the ankle, as opposed to minor amputation, being an amputation at or below metatarsal level, preserving functionality of the foot) | up to 12 months |
| A.Z. Sint-Blasius | Recruiting | Dendermonde | East-Flanders | 9200 | Belgium |
|
| OLV Aalst | Recruiting | Aalst | Oost-Vlaanderen | 9300 | Belgium |
|
| RZ Heilig Hart Hospital | Recruiting | Tienen | 3300 | Belgium |
|
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |