ILLUMENATE Below-The-Knee (BTK) Arteries: a Post Market Clinical Study (BTK PMS)

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Critical Limb Ischemia, CLI, Claudication, PAD, BTK, Below The Knee Read More

Inclusion Criteria:

1. Subjects intended to be treated with the Stellarex 0.014" Drug-Coated Balloon for de-novo or restenotic lesions in native "below the knee" popliteal (P3 segment) and infra-popliteal arteries ending at the tibiotalar joint (ankle), as per the Instruction for Use (IFU).
2. Rutherford-Becker clinical category classification (RCC) 3 patients with claudication or RCC 4 or 5 subjects with documented Critical Limb Ischemia (CLI) defined as 2.1 RCC 3 subjects: subjects with severe claudication 2.2 RCC 4 subjects: subjects with persistent, recurring ischemic rest pain requiring analgesia for at least two weeks or 2.3 RCC 5 subjects: subjects with minor tissue loss of the foot or toes or
3. Age ≥18 years old.
4. Reconstitution of the target vessel at the ankle and run-off into a patent dorsalis pedis or plantar arteries defined as <50% stenosis by visual estimate.
5. Is able and willing to provide written informed consent and comply with all required follow-up evaluations within the defined follow-up visit windows prior to enrollment in the study.
6. Life expectancy > 1 year.

Exclusion Criteria:

1. Subjects with any medical condition that would make him/her inappropriate for treatment with the Stellarex balloon as per the Instructions for Use (IFU) or in the opinion of the investigator.
2. Has impaired renal function defined as serum creatinine >2.5 mg/dl that cannot be adequately pre-treated or subjects on dialysis.
3. Subjects already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
4. Subjects that in the judgment of the investigator would require treatment of the contralateral limb within 3 days prior to the index procedure or 30 days after. Note: Unless contralateral treatment is required to facilitate adequate access to the target lesion (e.g. contralateral iliac).

5. Previous or planned surgical or catheter-based procedure within 3 days before or 30 days after the index procedure. Note: This excludes successful inflow artery treatment within the same hospitalization or a documented preplanned minor amputation.

   • Successful inflow artery treatment is defined as attainment of residual diameter stenosis ≤ 30% without major vascular complication (e.g. absence of flow-limiting dissection, embolic event). These inflow arteries must be treated without the need for laser, atherectomy, thrombectomy, cryoplasty, brachytherapy and cutting/scoring balloons. Treatment with a Stellarex DCB of the inflow lesion, if according to its intended use, is allowed.
6. Prior endovascular treatment of the target lesion within three (3) months of the index procedure.
7. Prior stent placement in the target lesion(s).
8. Single focal lesion < 4cm in length in the absence of additional treatable popliteal or infra-popliteal lesions.
9. Subjects confined to bed that are completely non-ambulatory.
10. For RCC 5 subjects: Non-arterial ulcers such as venous ulcers, neurotrophic ulcers, heel pressure ulcers, ulcers potentially involving calcaneus region or ulcers in the proximal one-half of the foot or higher (from mid-foot and higher going up the leg).
11. Subjects scheduled to undergo a planned major amputation.
12. Presence of concentric calcification that precludes adequate vessel preparation per IFU.