Remedy, Biodegradable Peripheral Stent Registry

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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, Senior)
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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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Belgium
University Hospital Ghent
Ghent, Belgium

Sponsors and Collaborators

be Medical

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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