NCT03124875 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Clair DG, Mustapha JA, Shishehbor MH, Schneider PA, Henao S, Bernardo NN, Deaton DH
PROMISE I: Early feasibility study of the LimFlow System for percutaneous deep vein arterialization in no-option chronic limb-threatening ischemia: 12-month results. J Va
Mustapha JA, Saab FA, Clair D, Schneider P
Interim Results of the PROMISE I Trial to Investigate the LimFlow System of Percutaneous Deep Vein Arterialization for the Treatment of Critical Limb Ischemia. J Invasive Cardiol. 2019 Mar;31(3):57-63.

Pilot Study to Investigate Safety, Effectiveness and Feasibility of LimFlow Stent Graft System for Creating an AV Fistula for the Treatment of Critical Limb Ischemia

Details for clinical trial NCT03124875

Clinical trial NCT03124875 - References