SELUTION SLR™ 014 BTK: A Prospective Randomized Multicenter Single Blinded Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the Treatment of Below-the-Knee (BTK) Atherosclerotic Disease in Patients With Chronic Limb Threatening Ischemia (CLTI)

Summary

This study aims to demonstrate superior efficacy and equivalent safety of the SELUTION SLR™ DEB 014 compared to plain (uncoated) balloon angioplasty in the treatment of peripheral arterial disease (PAD) in the BTK arteries in CLTI patients.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Device
  SELUTION SLR™ DEB 014

  a non-surgical procedure that uses a catheter to inflate a drug-eluting balloon to open up peripheral below-the-knee arteries that have been narrowed by chronic limb-threatening ischemia

• Device
  Plain (Uncoated) Balloon Angioplasty (PTA)

  a non-surgical procedure that uses a catheter to inflate a commercially available, non-drug-eluting balloon to open up peripheral below-the-knee arteries that have been narrowed by chronic limb-threatening ischemia

Locations (48)