Stellarex Vascular E-Registry (SAVER)

Spectranetics

Status: Completed

Conditions: Peripheral Arterial Disease

Treatments: Device: Percutaneous Transluminal Angioplasty

Study type: Observational

Funder types: Industry

Identifiers

NCT02769273

D029260

Details and patient eligibility

About

Prospective, international, multi-center, single arm, observational study to continue to assess the treatment by the Stellarex™ OTW Drug-coated Angioplasty Balloon in superficial femoral and/or popliteal arteries according to the Instructions for Use in a broad, real-world, claudicant or ischemic rest pain patients population per the institution's standard practice.

Enrollment: 1,900 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients intended to be treated with Stellarex for de-novo or restenotic lesions of the femoro-popliteal arteries
• Rutherford Clinical Category (RCC) 2-3 or 4 indicated for a Percutaneous Transluminal Angioplasty according to local applicable guidelines
• Patients intended to be treated with Stellarex for de-novo or restenotic lesions of the superficial femoral, popliteal and/or infra-popliteal arteries*
• Rutherford Clinical Category (RCC) 2-6 indicated for a Percutaneous Transluminal Angioplasty according to local applicable guidelines
• Age ≥18 years old
• Life expectancy > 1 year
• Is able and willing to provide written informed consent prior to enrollment in the study (as applicable)
• Is able and willing to come on site or to be contacted by phone for the follow-up

Exclusion criteria

Patients with any medical condition that would make him/her inappropriate for treatment with Stellarex as per Instructions for Use (IFU) or investigator's opinion

• Patient already enrolled in other investigational (interventional) studies that would interfere with study endpoints

• Patients with severe disease of foot circulation defined as:

  • "desert foot" (absence of any angiographically visible arterial network below the ankle)
  • Or lack of a patent (<50%DS) and hemodynamically relevant wound related arterial pathway in the foot

• Patients confined to bed that are completely non ambulatory

Trial design

1,900 participants in 2 patient groups

Cohort 1

Description:

RCC 2-3

Treatment:

Device: Percutaneous Transluminal Angioplasty

Cohort 2

Description:

RCC 4-6 (CLI)

Treatment:

Device: Percutaneous Transluminal Angioplasty