Peripheral Arterial Disease
Conditions
Brief summary
Prospective, international, multi-center, single arm, observational study to continue to assess the treatment by the Stellarex™ OTW Drug-coated Angioplasty Balloon in superficial femoral and/or popliteal arteries according to the Instructions for Use in a broad, real-world, claudicant or ischemic rest pain patients population per the institution's standard practice.
Interventions
Sponsors
Spectranetics Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients intended to be treated with Stellarex for de-novo or restenotic lesions of the femoro-popliteal arteries * Rutherford Clinical Category (RCC) 2-3 or 4 indicated for a Percutaneous Transluminal Angioplasty according to local applicable guidelines * Patients intended to be treated with Stellarex for de-novo or restenotic lesions of the superficial femoral, popliteal and/or infra-popliteal arteries\* * Rutherford Clinical Category (RCC) 2-6 indicated for a Percutaneous Transluminal Angioplasty according to local applicable guidelines * Age ≥18 years old * Life expectancy \> 1 year * Is able and willing to provide written informed consent prior to enrollment in the study (as applicable) * Is able and willing to come on site or to be contacted by phone for the follow-up
Exclusion criteria
Patients with any medical condition that would make him/her inappropriate for treatment with Stellarex as per Instructions for Use (IFU) or investigator's opinion * Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints * Patients with severe disease of foot circulation defined as: * desert foot (absence of any angiographically visible arterial network below the ankle) * Or lack of a patent (\<50%DS) and hemodynamically relevant wound related arterial pathway in the foot * Patients confined to bed that are completely non ambulatory
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint Cohort 1 - RCC 2-3: | 12 months post-procedure | Freedom from clinically-driven Target Lesion Revascularization (CD-TLR) at 12 months post- procedure. |
| Primary Safety Endpoint-Cohort 1 - RCC 2-3 | 30 days post-procedure - 12Month post procedure | Freedom from device and procedure- related death through 30 days post-procedure and freedom from target limb major amputation and CD-TLR through 12 months post-procedure. |
| Primary effectiveness endpoint: Cohort 2 - RCC 4-6 (CLI) | 6 Months post procedure | Freedom from CD-TLR at 6 months post-procedure. |
| Primary safety endpoint-Cohort 2 - RCC 4-6 (CLI) | 30days | Freedom from Composite MALE and POD through 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate and Freedom from events as specified in the description :Cohort 1 - RCC 2-3 | as specified in the description | * All-cause mortality at 12, 24 and 36 months post- procedure * Cardiovascular death at 12, 24, 36 months post- procedure * Procedural complication defined as occurrence of death, stroke, myocardial infraction, emergent surgical revascularization, significant distal embolization in target limb, or thrombosis of target vessel through the end of the procedure * Device or procedure related death at 30 days * Major target limb amputation at 12, 24, 36 months post-procedure * CD-TLR through 12 (rate only), 24 and 36 months * Clinically Driven- Target Vessel Revascularization (CD- TVR) through 12, 24 and 36 months |
| Rate and Freedom-from-Cohort 2 - RCC 4-6 | As specified in the description | All-cause mortality at 6, 12, 24 and 36 months post- procedure * Cardiovascular death at 6, 12, 24, 36 months post- procedure * Procedural complication defined as occurrence of death, stroke, myocardial infraction, emergent surgical revascularization, significant distal embolization in target limb, or thrombosis of target vessel through the end of the procedure * Device or procedure related death at 30 days o Major target limb amputation at 6, 12, 24, 36 months post-procedure * CD-TLR through 6 (rate only), 12, 24 and 36 months o Clinically Driven- Target Vessel Revascularization (CD- TVR) through 6, 12, 24 and 36 months * Wound healing rate through 6, 12, 24, and 36 months post-procedure * Minor amputation through 6, 12, 24 and 36 months * Amputation-free survival through 6, 12, 24 and 36 months |
Countries
Austria, Belgium, France, Germany, Italy, United Kingdom
Outcome results
None listed