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| Name | Class |
|---|---|
| KCRI | OTHER |
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The aim of this study is to assess the safety and efficacy of PAD treatment by revascularization with new cobalt-chromium sirolimus stent implantation, which is expandable on balloon PERS (CoCr SES) compared to cobalt-chromium balloon-expandable (Neptun C) stent (CoCr BMS) in patients with symptomatic iliac arteries disease requiring revascularization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PERS stent | Experimental | 20 Patients will receive PERS stent |
|
| NEPTUN C stent | Active Comparator | 20 Patients will receive NEPTUN C stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PERS stent | Device | PERS® is a cobalt-chromium stent, made of cobalt-chromium alloy with drug (Sirolimus) and biodegradable polymer controlling drug elution. The length of the stent is selected to cover the treated lesion with a margin of 5 mm proximal and distal, while the diameter of the stent will be selected based on the QVA measurement (balloon to vessel ratio 1:1). |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of MAE | Occurrence of major adverse event (MAE) in 12 months follow up, defined as death related to stent implantation of procedure, amputation above metatarsus in treated limb due to vascular complication or/and reintervention in treated lesion (TLR). | 12 months FU |
| Measure | Description | Time Frame |
|---|---|---|
| Vessel patency | Vessel patency 30 days, 6 and 12 months after the initial procedure assessed by Dupplex Doppler | 30 days, 6 months and 12 months FU |
| Success of implanting the device | Success of implanting the device, defined as residual stenosis ≤30% in angiographic assessment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Małopolskie Centrum Sercowo-Naczyniowe PAKS American Heart of Poland S.A. | Chrzanów | 32-500 | Poland | |||
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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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| NEPTUN C stent | Device | Neptun C is balloon-expanding cobalt-chromium stent. |
|
| Directly after implantation, at the end of endovascular index procedure |
| Procedural success | Procedural success, defined as residual stenosis ≤30% in angiographic assessment and lack of procedurę related SAE. | Up to 7 days after procedure |
| Clinical success | Clinical success, defined as improvement in Rutherford classification for at least 1 point. | During follow-up visits: 30 days, 6 months and 12 months |
| ABI (ankle-brachial index) change | ABI (ankle-brachial index) change after 30 days and 12 months | 30 days and 12 months FU |
| Mortality rate | Mortality rate after 30 days, 6 months and 12 months (cardiovascular deaths) | 30 days, 6 months and 12 months FU |
| Artery patency in Duplex Doppler USG: Maximum velocity flow | Maximum velocity flow assessed by Dupplex Doppler | 30 days, 6 months and 12 months FU |
| Artery patency in Duplex Doppler USG: % of diameter stenosis | % of diameter stenosis (DS in target lesion) assessed by Dupplex Doppler | 30 days, 6 months and 12 months FU |
| Samodzielny Publiczny Szpital Kliniczny nr 1 |
| Lublin |
| 20-081 |
| Poland |
| Szpital Eskulap Centrum Leczenia Chorób Serca i Naczyń | Osielsko | 86-031 | Poland |
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |