Status:
COMPLETED
ILLUMENATE Below-The-Knee (BTK) Arteries: a Post Market Clinical Study
Lead Sponsor:
Spectranetics Corporation
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The objective of this prospective, multi-center, single arm study is to obtain further data on the safety and performance of the StellarexTM 0.014" OTW Drug-coated Angioplasty Balloon in the treatment...
Detailed Description
There is a significant amount of evidence that the use of Paclitaxel-coated balloons in the treatment of peripheral arterial disease (PAD) has demonstrated favorable outcomes when used to treat lesion...
Eligibility Criteria
Inclusion
- 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).
- 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
- Age ≥18 years old.
- 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.
- 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.
- Life expectancy \> 1 year.
Exclusion
- 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.
- Has impaired renal function defined as serum creatinine \>2.5 mg/dl that cannot be adequately pre-treated or subjects on dialysis.
- Subjects already enrolled in other investigational (interventional) studies that would interfere with study endpoints.
- 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).
- 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.
- Prior endovascular treatment of the target lesion within three (3) months of the index procedure.
- Prior stent placement in the target lesion(s).
- Single focal lesion \< 4cm in length in the absence of additional treatable popliteal or infra-popliteal lesions.
- Subjects confined to bed that are completely non-ambulatory.
- 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).
- Subjects scheduled to undergo a planned major amputation.
- Presence of concentric calcification that precludes adequate vessel preparation per IFU.
Key Trial Info
Start Date :
April 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 23 2023
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03395236
Start Date
April 20 2018
End Date
August 23 2023
Last Update
January 24 2024
Active Locations (10)
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1
Cardiologisches Centrum Bethanien
Frankfurt, Germany
2
Asklepios Kliniken Hamburg GmbH
Hamburg, Germany
3
Klinik Immenstadt, Herz und GefaSzentrum Immenstadt
Immenstadt im Allgäu, Germany
4
Universitatsmedizin der Johannes Gutenberg-Universitat Mainz
Mainz, Germany