Details

IRB Study Number 23-239

Status Recruiting

Location Fairview Hospital

Institute Heart and Vascular Institute

Description

Description

Prospective, multi-center, single blinded, randomized, controlled, superiority clinical trial. Subjects will be randomized 2:1 to treatment with either the Selution SLR DEB or a commercially available plain (uncoated) angioplasty balloon (POBA). This study compares the Selution SLR DEB to the POBA in the treatment of peripheral arterial disease (PAD) in the superficial femoral artery (SFA) and proximal popliteal artery (PPA).

Inclusion Criteria

Inclusion Criteria

  • Subject age is ≥ 18 years or minimum legal age as required by local regulations.
  • Life expectancy > 1 year in opinion of investigator.
  • Documented ischemia with Rutherford classification category 2, 3, or 4 and symptoms of > 2 weeks duration.
  • Target lesion(s) in the SFA or PPA.
  • Able to walk without the assistance of a walker.
  • Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.
  • Female subjects of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure.

Exclusion Criteria

Exclusion Criteria

  • Other surgical or endovascular procedure in the target limb that occurred within 14 days prior to index procedure or is planned for within 30 days following index procedure, with exception for diagnostic angiography.
  • Inability to tolerate dual antiplatelet therapy.
  • Known hypersensitivity or allergy to Sirolimus or other pharmacologic agents, such as contrast agent.
  • Stroke or MI within 3 months of enrollment.
  • Symptom onset less than 14 days prior to index procedure (acute limb ischemia).
  • Lower limb disease in the contralateral leg that requires treatment at the index procedure.
  • Prior vascular surgery (including bypass or endarterectomy) of abdominal aorta, iliac arteries, or arteries of the index limb.
  • Non-atherosclerotic disease of the index limb.
  • Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.