Peripheral Arterial Disease
Conditions
Brief summary
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.
Interventions
DEVICEPERS stent
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).
DEVICENEPTUN C stent
Neptun C is balloon-expanding cobalt-chromium stent.
Sponsors
KCRI
Balton Sp.zo.o.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. De novo lesion or restenosis without previously implanted stent, in a common or external iliac artery with a reference diameter of 5 to 12 mm, length up to 10 cm and stenosis ≥ 50% and ≤ 99% (in quantitative assessment by peripheral angiography), which may be treated with one stent or total occlusion of vessels up to 50 mm long. 2. Ability to cross the lesion with guidewire (assessed during diagnostic angiography). 3. ABI ankle-brachial index \<0.9. 4. Signs of lower limb ischemia based on the Rutherford scale in the range from 2 to 4. 5. Age ≥ 18 years. 6. Patient signed informed consent form.
Exclusion criteria
1. Life expectancy less than two years. 2. Chronic kidney disease in stage III-V. 3. Lesion in the previously implanted by-pass. 4. Target lesion is a chronic total occlusion of significant length, not eligible for percutaneous revascularization. 5. Acute lower limb ischemia. 6. Stenosis (\> 50%) or occlusion proximally to the lesion being treated. 7. Angiographically confirmed thrombus in the lesion to be treated. 8. Treatment requires an atherectomy to deliver stent to treated lesion. 9. Known allergy or hypersensitivity to clopidogrel. 10. Hemorrhagic stroke in the last three months. 11. Contraindications for acetylsalicylic acid (hypersensitivity, hemorrhagic diathesis). 12. Pregnancy or women of childbearing potential not using effective contraception. 13. Active inflammation at the planned access site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of MAE | 12 months FU | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Success of implanting the device | Directly after implantation, at the end of endovascular index procedure | Success of implanting the device, defined as residual stenosis ≤30% in angiographic assessment. |
| Procedural success | Up to 7 days after procedure | Procedural success, defined as residual stenosis ≤30% in angiographic assessment and lack of procedurę related SAE. |
| Clinical success | During follow-up visits: 30 days, 6 months and 12 months | Clinical success, defined as improvement in Rutherford classification for at least 1 point. |
| Vessel patency | 30 days, 6 months and 12 months FU | Vessel patency 30 days, 6 and 12 months after the initial procedure assessed by Dupplex Doppler |
| Mortality rate | 30 days, 6 months and 12 months FU | Mortality rate after 30 days, 6 months and 12 months (cardiovascular deaths) |
| Artery patency in Duplex Doppler USG: Maximum velocity flow | 30 days, 6 months and 12 months FU | Maximum velocity flow assessed by Dupplex Doppler |
| Artery patency in Duplex Doppler USG: % of diameter stenosis | 30 days, 6 months and 12 months FU | % of diameter stenosis (DS in target lesion) assessed by Dupplex Doppler |
| ABI (ankle-brachial index) change | 30 days and 12 months FU | ABI (ankle-brachial index) change after 30 days and 12 months |
Countries
Poland
Outcome results
None listed