ClinicalTrials.Veeva

Menu

Stellarex Vascular E-Registry (SAVER)

S

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
  • 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 that in the judgment of the investigator would need treatment below the knee before and/or during the index procedure.

Trial contacts and locations

46

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems