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The in.pact sfa trial was designed to test the safety and efficacy of the in.pact admiral dcb for the treatment of patients with symptomatic pad in the superficial femoral and proximal popliteal artery. New engl j med 2015;
The data demonstrate strong durability through three years with superior performance in both.
In pact sfa trial. The data demonstrate strong durability through three years with superior performance in both. 107 men) at 15 centers. Actual study completion date :
New engl j med 2015; The in.pact clinical programme covers multiple trials and patient populations with varying disease states. Laird et al., j am coll cardiol.
Methods study design the in.pact sfa trial is. The in.pact sfa trial was designed to test the safety and efficacy of the in.pact admiral dcb for the treatment of patients with symptomatic pad in the superficial femoral and proximal popliteal artery. Medtronic, inc.) versus standard percutaneous transluminal angioplasty (pta) for the treatment of superficial femoral artery (sfa) and proximal popliteal artery lesions.
The predominant risk factors were hypertension (104, 72.7%) and diabetes mellitus (66, 46.2%). The in.pact sfa trial enrolled in 2 phases: First and only independently adjudicated, randomized pivotal ide trial to demonstrate durable, superior treatment effect with a dcb over pta through three years.
The in.pact clinical program covers multiple trials and patient populations with varying disease states. In.pact sfa i and in.pact sfa ii. In.pact dcb (n = 220) vs.
Primary patency benefit was sustained to 3 years with minimal to no late catch up. Actual primary completion date : • prospective, multicenter eu and us, randomized (2:1), single blinded • independent and blinded duplex ultrasound core lab [1], angiographic core lab [2], and clinical events committee [3] • independent data safety monitoring board [3] • external monitoring with 100% source data verification • subjects followed up to 5 years.
Laird, md, of the adventist heart & vascular institute, st.