ProspectIve, MuLti-Center Study to EvaLUate TreatMent of subjects with OcclusivE Disease with a Novel PAcliTaxel-CoatEd Angioplasty Balloon in Below-The- Knee (BTK) arteries: a Post Market clinical Study

Completed

• Conditions: 10003216; narrowing of blood vessel under the knee; vessel stenosis; 10003184

• Registration Number: NL-OMON55654
• Lead Sponsor: Philips Image Guided Therapy Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified