A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Effectiveness of the SELUTION SLR* 014 Drug Eluting Balloon in the Treatment of Below-the-Knee (BTK) Atherosclerotic Disease in Patients with Chronic Limb Threatening Ischemia (CLTI)

Not yet recruiting

• Conditions: Chronic Limb Threatening Ischemia (CLTI); Peripheral Artery Disease (PAD); 10047043; 10003184; 10003216

• Registration Number: NL-OMON56385
• Lead Sponsor: M.A. Med Alliance SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

CLINICAL INCLUSION CRITERIA
1. Subject age is >= 18 years or older depending on local regulations.
2. Subject life expectancy is >= 1 year.
3. Subject has documented chronic limb-threatening ischemia in the target limb
with Rutherford classification category 4, 5 or 6 and symptoms of > 2 weeks
duration.
4. Subject is willing and able to provide written informed consent and comply
with study procedures and required follow-up evaluations.
5. Female subjects only: If female, then subjects of childbearing potential
must be non-breastfeeding and have a negative pregnancy test <= 7 days before
the procedure and be prepared to use effective contraception for 24 months
after treatment.

ANGIOGRAPHIC INCLUSION CRITERIA
1. Target lesion(s) must lie distal to the tibial plateau and above the
tibiotalar joint line within the BTK arteries. There is no limitation on total
target lesion length. Two in-line areas of stenosis are considered multiple
lesions if a) there is 2 cm of normal appearing artery between them, and b) at
least 1 cm of the normal appearing artery is not treated. Otherwise, the
lesions should be considered a single lesion and the entire segment should be
treated with the assigned devices. If multiple SELUTION* SLR DEB are used, the
total allowable drug dose per patient by summing the drug dose per individual
balloons must be <= 4396µg.
2. Distal tibial and pedal runoff for each target lesion treated is patent
(defined as <50% stenosis of the associated distal tibial artery and pedal
outflow arteries).
3. Target vessel reference diameter(s) are >= 2mm and <= 4mm.
4. Arterial inflow (ipsilateral common iliac, external iliac, common femoral
and profunda femoris arteries, SFA and popliteal artery proximal to the tibial
plateau) is free from >= 50% stenosis as confirmed on angiography.
a) If >= 50% inflow stenosis of the common and external iliac, superficial
femoral, and proximal popliteal arteries is found, it must be successfully
treated during the index procedure.
b) Completion angiography must confirm successful treatment of inflow disease
(<=30% residual stenosis, no distal embolization, and no Grade C or greater
dissection ) prior to pre-dilation and randomization of the BTK target
lesion(s).
5. Successful pre-dilatation (defined by <= 30% residual stenosis, no distal
embolization, and no Grade C or greater dissection) of all target lesions with
uncoated PTA catheter sized to the reference vessel diameter must be
accomplished before randomization.

Exclusion Criteria

CLINICAL EXCLUSION CRITERIA
1. Subject underwent failed POBA intervention on the target lesion(s) within 3
months of the index procedure.
2. Subject underwent surgical or endovascular procedure within 14 days prior to
index procedure, or is planned for surgical or endovascular procedure within 30
days following index procedure, with the exception of:
a) Diagnostic angiography prior to index procedure
b) Treatment of contralateral iliac disease and/or treatment of inflow disease
of the index limb that is completed prior to randomization
c) Planned amputation of digit(s) of the index limb at the phalangeal level
d) Debridement of a foot wound
3. Subject has infrainguinal disease in the contralateral leg that requires
treatment at the index procedure, or treatment planned to occur within 14 days
prior to the index procedure or within 30 days after the index procedure.
4. Subject is planned to undergo major amputation of either leg.
5. Subject has undergone any prior major amputation of the ipsilateral
extremity.
6. Subject is unable to tolerate dual antiplatelet therapy.
7. Subject has undergone non-coronary artery treatment with any limus based
drug-coated or drug-eluting balloon/stent/other device within one year prior to
index procedure.
8. Subject has undergone prior DCB, DES or BMS treatment of current target
lesion(s).
9. Subject has known hypersensitivity or allergy to Sirolimus or other
pharmacologic agents (such as contrast agent, heparin, bivalirudin) required
for the procedure, and this hypersensitivity/allergy cannot be adequately
pre-treated.
10. Subject has experienced stroke or MI within 3 months of index procedure.
11. Subject had onset of index limb symptoms less than 14 days prior to index
procedure (acute limb ischemia).
12. Subject has undergone prior bypass of arteries of the index limb (except
for iliac artery bypass).
13. Subject has non-atherosclerotic disease of the index limb (including
aneurysmal disease, vasculitis, Buerger*s disease)
14. Subject has target lesion(s) that require (pre-)treatment with alternative
therapies such as thrombolysis, thrombus aspiration, cutting/scoring/contoured
balloon, stenting, laser, cryoplasty, brachytherapy, intravascular lithotripsy,
or re-entry device.
15. Subject has target lesion(s) that require treatment via pedal site.
16. Subject has target lesion(s) that require access via upper extremity
arteries.
17. Subject has extensive tissue loss salvageable only with complex foot
reconstruction or non-traditional trans metatarsal amputations. This includes
subjects with:
a) Osteomyelitis involving, more proximal to, the metatarsal head(s)
b) Any heel wound or wound with calcaneal bone involvement
c) Wounds that are deemed to be neuropathic or non-ischemic in nature
d) Wounds that would require flap coverage or complex wound management for
large soft tissue defect
e) Full-thickness wounds on the dorsum of the foot with exposed tendon or bone
f) Venous or mixed wounds.
18. Subject has hypercoagulable state or disorder, or coagulopathy, including
platelet count less than 100,000 per microliter.
19. Subject has systemic infection (WBC > 12,000 and febrile). [Note:
Enrollment permitted after successful treatment of infection with resolution of
leukocytosis and/or febrile state].
20. Subject h

Study & Design

• Study Type: Interventional
• Study Design: Not specified