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Completed

NCT Number: NCT02769273

Stellarex Vascular E-Registry

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Percutaneous Transluminal Angioplasty

Device

Other names: Stellarex™ OTW Drug-coated Angioplasty Balloon

Primary outcomes

  1. Primary Efficacy Endpoint Cohort 1 - RCC 2-3:

    Time frame: 12 months post-procedure

    Freedom from clinically-driven Target Lesion Revascularization (CD-TLR) at 12 months post- procedure.

  2. Primary Safety Endpoint-Cohort 1 - RCC 2-3

    Time frame: 30 days post-procedure - 12Month post procedure

    Freedom from device and procedure- related death through 30 days post-procedure and freedom from target limb major amputation and CD-TLR through 12 months post-procedure.

  3. Primary effectiveness endpoint: Cohort 2 - RCC 4-6 (CLI)

    Time frame: 6 Months post procedure

    Freedom from CD-TLR at 6 months post-procedure.

  4. Primary safety endpoint-Cohort 2 - RCC 4-6 (CLI)

    Time frame: 30days

    Freedom from Composite MALE and POD through 30 days

Secondary outcomes

  1. Rate and Freedom from events as specified in the description :Cohort 1 - RCC 2-3

    Time frame: as specified in the description

    • All-cause mortality at 12, 24 and 36 months post- procedure
    • Cardiovascular death at 12, 24, 36 months post- procedure
    • Procedural complication defined as occurrence of death, stroke, myocardial infraction, emergent surgical revascularization, significant distal embolization in target limb, or thrombosis of target vessel through the end of the procedure
    • Device or procedure related death at 30 days
    • Major target limb amputation at 12, 24, 36 months post-procedure
    • CD-TLR through 12 (rate only), 24 and 36 months
    • Clinically Driven- Target Vessel Revascularization (CD- TVR) through 12, 24 and 36 months

  2. Rate and Freedom-from-Cohort 2 - RCC 4-6

    Time frame: As specified in the description

    All-cause mortality at 6, 12, 24 and 36 months post- procedure

    • Cardiovascular death at 6, 12, 24, 36 months post- procedure
    • Procedural complication defined as occurrence of death, stroke, myocardial infraction, emergent surgical revascularization, significant distal embolization in target limb, or thrombosis of target vessel through the end of the procedure
    • Device or procedure related death at 30 days o Major target limb amputation at 6, 12, 24, 36 months post-procedure
    • CD-TLR through 6 (rate only), 12, 24 and 36 months o Clinically Driven- Target Vessel Revascularization (CD- TVR) through 6, 12, 24 and 36 months
    • Wound healing rate through 6, 12, 24, and 36 months post-procedure
    • Minor amputation through 6, 12, 24 and 36 months
    • Amputation-free survival through 6, 12, 24 and 36 months

Sponsors and collaborators

Lead sponsor

Spectranetics Corporation

Industry

Registry information

Acronym: SAVER

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
May 11, 2016
Registry last updated
Aug 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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