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Remedy, Biodegradable Peripheral Stent Registry

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ClinicalTrials.gov Identifier: NCT01420120
Recruitment Status : Completed
First Posted : August 19, 2011
Last Update Posted : July 16, 2015
Sponsor:
Information provided by:
be Medical

Study Description
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Brief Summary:
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.

Condition or disease
Peripheral Arterial Disease

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official 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.
Study Start Date : January 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Absence of clinically driven target lesion revascularization at 12 months. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with documented symptomatic occlusion and/or > 70% stenosis of SFA.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420120


Locations
Belgium
University Hospital Ghent
Ghent, Belgium
Sponsors and Collaborators
be Medical
More Information
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Responsible Party: Joris Coteur, study coordinator, .be medical
ClinicalTrials.gov Identifier: NCT01420120     History of Changes
Other Study ID Numbers: BM-REM-03-003
First Posted: August 19, 2011    Key Record Dates
Last Update Posted: July 16, 2015
Last Verified: July 2015

Keywords provided by be Medical:
Biodegradable stent, PAD

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
 Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases