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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.
Full 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 trial will be conducted in two phases.
Phase A is a prospective, multi-center, 1:1 randomized dual arm study of 20 subjects, evaluating the short-term safety of the Drug Eluting Temporary Spur Stent System compared to PTA to treat lesions in infrapopliteal arteries in subjects with critical limb ischemia (CLI). Thirty (30) day data from Subjects in Phase A will be evaluated by an independent Data Safety Monitoring Board (DSMB) and submitted to the Food and Drug Administration (FDA) for review. Phase A subjects will be rolled into Phase B.
Phase B is a prospective, multicenter, 1:1 randomized dual arm study of no less than 345 and up to 518 subjects, evaluating the safety and efficacy of the Drug Eluting Temporary Spur Stent System compared to PTA to treat lesions in infrapopliteal arteries in subjects with CLI.
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Inclusion criteria
Pre-Procedure Inclusion Criteria:
Angiographic Inclusion Criteria:
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:
Target vessel reconstitutes at or above the ankle, with the target treated segment ending at least 10 mm above the ankle joint.
Note:
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):
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:
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 criteria
Pre-procedure Exclusion Criteria:
Angiographic Exclusion Criteria
Primary purpose
Allocation
Interventional model
Masking
518 participants in 2 patient groups
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Central trial contact
Carolyn Mascho, BSN, DNP, AG-NP
Data sourced from clinicaltrials.gov
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