Status:
WITHDRAWN
Peripheral Microvascular Resistance as a Predictor for Limb Salvage
Lead Sponsor:
Hackensack Meridian Health
Collaborating Sponsors:
Abbott Medical Devices
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Salvaging a threatened limb is the key therapeutic objective for patients with critical limb ischemia, and the achievement of limb salvage is an independent predictor of patient morbidity and mortalit...
Eligibility Criteria
Inclusion
- Chronic critical limb ischemia (Rutherford 4-6).
- Age ≥18 years
- Ability and willingness to sign the IRB approved Informed Consent form
Exclusion
- Non-reconstructable chronic total occlusive disease of the proximal inflow vessels that would make flow reserve measurements impossible.
- Non-salvageable lower extremity due to infection or overwhelming per-existing tissue loss (most critical Rutherford 6 patients).
- Inability to understand the study or a history of non-compliance with medical advice;
- History of any cognitive or mental health status that would interfere with study participation;
- Currently enrolled in any pre-approval investigational study.
- Female subjects who are pregnant or nursing or planning to become pregnant within the study period;
- Known sensitivity to contrast media, which can't be adequately pre-medicated;
- Expected life span less than 6 months.
- Unable to read/understand/sign the English Language consent form
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06014242
Start Date
September 15 2025
End Date
September 15 2026
Last Update
September 24 2025
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