Drug Eluting Temporary Spur Stent System vs Percutaneous Balloon Angioplasty for the Treatment of… (NCT06122974) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Drug Eluting Temporary Spur Stent System vs Percutaneous Balloon Angioplasty for the Treatment of Critical Limb Ischemia
518 participantsStarted 2026-08
Plain-language 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 primary treatment in the infrapopliteal arteries for the treatment of de novo or restenotic lesions.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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
✓. Inflow lesions treated intraprocedure must be treated first, prior to consideration of treatment of infrapopliteal lesions.
Exclusion criteria
✕. Subject unwilling or unlikely to comply with the 5-year duration of the study in the opinion of the investigator.
✕. Subject is pregnant or planning to become pregnant during the course of the trial.
✕. Subject is breastfeeding or planning to breastfeed during the course of the trial.
✕. Subject has an active systemic infection that is not controlled at the time of the procedure, including septicemia or bacteremia.
✕. Subject has osteomyelitis proximal to the phalanges of the target foot. Osteomyelitis in the digit(s) of the target foot is permitted.
✕. Wounds in the target limb must be confined to the foot below the ankle.
✕. Heel wounds on the target foot are excluded; wounds on the plantar surface of the hindfoot are permitted.
✕. Planned major (above the ankle) amputation of the target limb. A planned or previous minor (transmetatarsal amputation or digit amputation) amputation) is permitted.