A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatm… (NCT05358353) | Clinical Trial Compass
CompletedNot Applicable
A Prospective Single-Arm Multicenter StuDy of the BarE TEmporary SPur StEnt System foR the tREatment of Vascular Lesions Located in the infrapoplitEal Arteries beLow the Knee (DEEPER REVEAL)
United States130 participantsStarted 2022-10-18
Plain-language summary
This is a prospective, multicenter, single arm study designed to evaluate the safety and efficacy of the Temporary Bare Spur Stent System (Spur Stent System).
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 witness, including a family member, sign on their behalf.
✓. Life expectancy greater than 1 year in the investigator's opinion.
✓. Male or non-pregnant female ≥18 years of age at time of consent.
✓. Subjects must have chronic (greater than 14 days) symptoms of limb ischemia, determined by clinical symptoms of Rutherford class 4-5, rest pain (R 4), 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 3 days prior to the index procedure or greater than or equal to 7 days following the index procedure.
✓. Stenotic, restenotic, or occlusive lesions located in the infrapopliteal vessels, with target lesion that can be successfully crossed via the true lumen with a guidewire (no subintimal crossing).
✓. Iliac, SFA and popliteal inflow lesions can be treated using standard of care during the index procedure or greater than or equal to 3 days prior.
✓. 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 1-year duration of the study in the opinion of the investigator.
What they're measuring
1
Primary Efficacy Endpoint: Percentage of Participants With Technical Success of the Bare Temporary Spur Stent
Timeframe: At the end of the Index Procedure
2
Co-Primary Safety Endpoint: Percentage of Patients With no Major Adverse Limb Event (MALE) or Peri-operative Death (POD) at 30 Days Post Procedure
✕. Subject is pregnant or planning to become pregnant 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. Osteomyelitis in the digit(s) of the target foot is permitted.
✕. Wounds must be confined to the foot below the ankle. Heel wounds are excluded.
✕. Planned major (above the ankle) amputation of the target limb. A planned or previous minor (trans metatarsal amputation or digit amputation) is permitted.
✕. Recent myocardial infarction or stroke less than 90 days prior to the index procedure.
✕. Symptomatic acute heart failure NYHA class III or greater.