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Completed

NCT Number: NCT01420120

Remedy, Biodegradable Peripheral Stent Registry

This is a prospective multicenter registry to evaluate safety and performance of the REMEDY, biodegradable peripheral stent for the treatment of occluded or stenotic superficial femoral arteries. Patients will be followed for a period of 1 year.

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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

University Hospital Ghent

Ghent, Belgium

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with symptomatic leg ischemia requiring treatment of SFA artery or proximal popliteal artery located within the following parameters:
  • 1 cm from the femoral bifurcation in the SFA
  • 3 cm from the proximal margin of the intercondylar fossa
  • Rutherford-Becker Category 2-5. In patients with bilateral lesions, the highest Rutherford Category limb should be treated. Only 1 leg can be included.
  • Single lesion which can be covered by one stent.
  • Target vessel reference diameter ≥ 4 mm and ≤ 6 mm (by visual estimate)
  • A patent popliteal artery free from significant stenosis (>50%) with at least one patent vessel runoff as confirmed by baseline angiography
  • Signed informed consent.

Exclusion criteria

  • Pregnancy
  • Previous stenting of target lesion
  • Acute ischemia
  • Untreated inflow disease of the ipsilateral pelvic arteries (more than 50% stenosis or occlusion). Inclusion of a patient is allowed in case inflow lesions are successfully treated during the index-procedure yielding less than 30% diameter stenosis.
  • Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy
  • Known intolerance to study medications or contrast agents.

Treatment and study plan

Primary outcomes

  1. Absence of clinically driven target lesion revascularization at 12 months.

    Time frame: 12 months

Secondary outcomes

  1. Technical success

    Time frame: During procedure

    Defined as a successful access and deployment of the device and determined by less than 30% residual stenosis by angiography at the baseline procedure.

  2. Clinical success

    Time frame: During procedure

    Defined as technical success without the occurrence of serious adverse events during procedure

  3. Primary and secondary patency rate

    Time frame: 12 months

    defined as < 50% diameter reduction and peak systolic velocity < 2.4 at 12 months.

  4. Ankle-Brachial Index improvement of ≥ 0.1

    Time frame: 1, 6 and 12 months

  5. Clinically driven target vessel revascularization

    Time frame: 6 and 12 months

  6. Major complications at 6 and 12 months, including amputation of a part of the foot, the leg below and above the knee.

    Time frame: 6 and 12 months

  7. Rutherford-Becker classification of chronic limb ischemia

    Time frame: 1, 6 and 12 months

Sponsors and collaborators

Lead sponsor

be Medical

Industry

Registry information

Official study title

A Prospective Multicenter Registry to Evaluate Safety and Performance of REMEDY, Biodegradable Peripheral Stent for the Treatment of Occluded or Stenotic Superficial Femoral Arteries.

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 19, 2011
Registry last updated
Jul 16, 2015

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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