Remedy, Biodegradable Peripheral Stent Registry - Full Text View

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:

MedlinePlus related topics: Peripheral Arterial Disease

U.S. FDA Resources

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420120

Locations


Belgium
University Hospital Ghent
Ghent, Belgium

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:	May 13, 2014
Health Authority:	Belgium: Ethics Committee

Keywords provided by be Medical:


Biodegradable stent, PAD

Additional relevant MeSH terms:


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

ClinicalTrials.gov processed this record on February 25, 2015