Clinical Trials Logo

Clinical Trial Summary

The purpose of the study is to demonstrate the safety and efficacy of the IN.PACT Admiral drug-coated balloon (DCB) in comparison to any standard balloon for treatment of peripheral arterial disease (PAD) in the superficial femoral artery and proximal popliteal artery.


Clinical Trial Description

The IN.PACT SFA Trial enrolled in 2 phases: IN.PACT SFA I and IN.PACT SFA II. The 150-patient IN.PACT SFA I phase is intended to support the second phase IN.PACT SFA II IDE trial with congruent design and protocol. Aggregate data from the two phases is intended to provide statistical power for the 12-month primary safety and effectiveness endpoints. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01566461
Study type Interventional
Source Medtronic Endovascular
Contact
Status Completed
Phase N/A
Start date March 2012
Completion date May 2018

See also
  Status Clinical Trial Phase
Completed NCT01947478 - MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery N/A
Recruiting NCT03687983 - Safety and Efficacy Study of GoldenFlow Peripheral Stent System N/A
Completed NCT02720003 - A Single Arm Trial Evaluating the BARD Lutonix Drug-Coated Balloon (LTX DCB) for Treatment of Femoropopliteal Arteries N/A
Completed NCT02063672 - Lutonix® Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal In-Stent Restenosis N/A
Completed NCT01816412 - LEVANT Japan Clinical Trial Phase 2
Completed NCT01412541 - Moxy Drug Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Femoropopliteal Arteries N/A
Recruiting NCT03683459 - Safety and Efficacy Study of FemFlow Drug-Eluting Peripheral Balloon Catheter N/A
Recruiting NCT03142347 - Remote Endarterectomy vs Remote Endarterectomy + Drug Coated Balloon (DCB) Angioplasty in Patients With the Femoral Artery Occlusive Disease N/A
Terminated NCT00810134 - Bypass or Thurpass for Superficial Femoral Artery Occlusion? Scandinavian Thurpass Study N/A
Active, not recruiting NCT05734157 - CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Artery N/A
Completed NCT02013271 - Lutonix® DCB for Treatment of Long Lesions in Femoropopliteal Arteries
Completed NCT04343196 - Digital Variance Angiography in Diagnostic Angiographies for Effective Radiation Dose Reduction N/A
Terminated NCT02813577 - Lutonix Drug Coated Balloon for Treatment of Femoropopliteal Arteries in United States Females (CONFIRM) N/A
Completed NCT03844724 - Drug-eluting PTA Balloon Dilatation Catheter in the Treatment of Peripheral Artery Stenosis or Occlusion N/A