Status:
NOT_YET_RECRUITING
Drug Eluting Temporary Spur Stent System vs Percutaneous Balloon Angioplasty for the Treatment of Critical Limb Ischemia
Lead Sponsor:
ReFlow Medical, Inc.
Conditions:
Critical Limb Ischemia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this trial is to evaluate the safety and efficacy of the Drug Eluting Temporary Spur Stent System compared to PTA. The Drug Eluting Temporary Spur Stent System is intended for use as a...
Detailed Description
This is a randomized controlled trial evaluating the safety and efficacy of the Drug Eluting Temporary Spur Stent System (Spur) compared to percutaneous transluminal balloon angioplasty (PTA). The tri...
Eligibility Criteria
Inclusion
- Pre-Procedure
- Subject willing and able to provide informed consent and able to comply with the study protocol and follow up. Subjects who are unable to sign due to a physical limitation may have a Legally Authorized Representative (LAR), including a family member, sign on their behalf.
- Life expectancy greater than 1 year in the investigator's opinion.
- Subject is greater than 18 years of age.
- Subjects must have chronic (greater than 14 days) symptoms of limb ischemia, determined by clinical symptoms of Rutherford class 4-5, rest pain (R4), and/or minor tissue loss (R5), that in the opinion of the investigator are not amenable to conservative medical therapy and require endovascular intervention for alleviation of symptoms and tissue preservation.
- For subjects with bilateral disease, planned treatment of the contralateral limb must either be performed greater than or equal to 7 days prior to the index procedure or greater than or equal to 30 days following the index procedure.
- Angiographic
- Stenotic, restenotic, or occlusive lesions with greater than or equal to 70% stenosis located in the infrapopliteal vessels, with target lesion that can be successfully crossed with a guidewire via the true lumen.
- Iliac, Superficial Femoral Artery (SFA) and popliteal inflow lesions can be treated using standard of care during the index procedure
- Note:
- Inflow lesions treated intraprocedure must be treated first, prior to consideration of treatment of infrapopliteal lesions.
- Treatment of in-stent restenosis in inflow treatment is permitted, provided that stents are not severely fractured or otherwise compromised.
- Distal embolic protection is strongly encouraged in cases where atherectomy is used.
- Inflow lesions must have a healthy vessel segment of greater than 30 mm between the study lesion and the treated segment, defined as less than 50% stenosis without aneurysmal segments.
- Inflow treatment must be successful, prior to treatment of the target lesion, resulting in stenosis less than or equal to 30%, without resulting flow limiting (Type D or greater) dissection, thrombus, or aneurysm by angiography prior to randomization.
- Target vessel reconstitutes at or above the ankle, with the target treated segment ending at least 10 mm above the ankle joint.
- Note:
- If the anterior tibial or posterior tibial arteries are treated, there must be inline flow to the foot.
- If the peroneal artery is treated, there must be at least one collateral supplying the foot.
- In all cases, patent runoff (no lesions with greater than 50% stenosis) must be present via the dorsalis pedis and/or plantar arteries.
- Target lesion must be located in the tibial arteries. If vessel sizing remains appropriate, treatment may extend into the distal popliteal (P3) segment.
- Target vessel reference diameter is measured to be greater than or equal to 2.5 and less than or equal to 4.25 mm in diameter assessed by one of the following methods after successful completion of guidewire crossing of the lesion site (visual estimate permitted):
- Intravascular Ultrasound (IVUS)
- Quantitative Vascular Angiography (QVA)
- Visual Estimate
- Target lesion length must be less than or equal to 210 mm cumulatively. Tandem lesions that are less than or equal to 4 cm should be treated as one lesion. Multiple discrete lesions may be treated provided cumulative length is less than or equal to 210 mm.
- Only one limb and one vessel may be enrolled per subject. If the investigator feels that multiple infrapopliteal vessels must be treated during the index procedure, a standard practice treatment may be performed in the non-target infrapopliteal vessel(s). This should be prior to randomization of and treatment of the target vessel whenever possible.
- Note:
- Distal embolic protection is strongly recommended in cases using atherectomy.
- Treatment of the target vessel/lesion may be performed only if treatment of the non-target vessel(s)/lesion(s) does not result in a complication which may compromise the outflow of the target lesion or result in a major adverse limb event.
- Treatment of non-target lesions must be parallel to, and not contiguous with, the target lesion.
- Retrograde access (in the infrapopliteal arteries) is permitted for lesion crossing; however, the randomized treatment must be deployed from antegrade (above the knee, either ipsilateral or contralateral) access.
Exclusion
- Pre-procedure
Key Trial Info
Start Date :
August 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2037
Estimated Enrollment :
518 Patients enrolled
Trial Details
Trial ID
NCT06122974
Start Date
August 1 2026
End Date
December 1 2037
Last Update
January 7 2026
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