Remedy, Biodegradable Peripheral Stent Registry

This study is currently recruiting participants.
Verified March 2013 by be Medical
Sponsor:
Information provided by:
be Medical
ClinicalTrials.gov Identifier:
NCT01420120
First received: August 16, 2011
Last updated: March 20, 2013
Last verified: March 2013
  Purpose

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
Peripheral Arterial Disease

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by be Medical:

Primary Outcome Measures:
  • Absence of clinically driven target lesion revascularization at 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Technical success [ Time Frame: During procedure ] [ Designated as safety issue: No ]
    Defined as a successful access and deployment of the device and determined by less than 30% residual stenosis by angiography at the baseline procedure.

  • Clinical success [ Time Frame: During procedure ] [ Designated as safety issue: Yes ]
    Defined as technical success without the occurrence of serious adverse events during procedure

  • Primary and secondary patency rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    defined as < 50% diameter reduction and peak systolic velocity < 2.4 at 12 months.

  • Ankle-Brachial Index improvement of ≥ 0.1 [ Time Frame: 1, 6 and 12 months ] [ Designated as safety issue: No ]
  • Clinically driven target vessel revascularization [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Rutherford-Becker classification of chronic limb ischemia [ Time Frame: 1, 6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01420120

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium
Contact: Frank Vermassen, MD, PhD    +32(0)93326388    frank.vermassen@ugent.be   
Sponsors and Collaborators
be Medical
  More Information

No publications provided

Responsible Party: Joris Coteur, study coordinator, .be medical
ClinicalTrials.gov Identifier: NCT01420120     History of Changes
Other Study ID Numbers: BM-REM-03-003
Study First Received: August 16, 2011
Last Updated: March 20, 2013
Health Authority: Belgium: Ethics Committee

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

ClinicalTrials.gov processed this record on April 17, 2014