A Post-market Registry of the MARIS-stent (Invatec) Implanted in the Superficial Femoral Artery

Study Overview
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Brief Summary
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The MARIS Register is a prospective, multicenter registry of implantation in the superficial femoral artery (SFA) with a CE marked stent (Maris / Invatec) intended to capture initial angiographic success, complication rate and symptomatic related revascularization by following the clinical process and duplex examinations at 6 and 12 month.

Detailed Description
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Recent data suggest that there is some evidence for a reduced restenosis rate for the implantation of a self expanding nitinol stent in the superficial femoral artery (SFA) compared to implantation of balloon expandable stents or single balloon inflation (ABSOLUTE study/FAST study). The purpose of the Maris Register is to evaluate the primary nitinol stent implantation in an all comer population with diseased SFA. The MARIS Register is a prospective, multicenter registry of the implantation of at least one at most five nitinol stents (Maris / Invatec) in the SFA without limitations for stenosis or occlusion length. The registry includes 998 patients from 13 German investigational sites. Clinical data are captured on electronic case report forms The primary endpoint is the target lesion revascularization after 12 month Secondary endpoints are : Restenosis rate > 50% according to ultrasound criteria Restenosis rate > 70% according to ultrasound criteria Location of restenosis (proximal, middle, distal AFS) Number of stent fractures (grading according to FESTO criteria) Procedure related complication rate Vascular complication rate within 12 month Amputations within 12 month Deaths within 12 month In order to measure the restenosis the peak systolic velocity (PSV) is to be measured in two sections during the duplex ultrasound examinations at 6 and 12 month. First measurement is performed 2cm proximal to the first stent, second measurement at the location where the maximum peak velocity over all lesions/all implanted stents is measured. The clinical status includes the patient´s Fontaine classification.

Official Title
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MARIS - Prospective, Multicenter Registry

Conditions
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Peripheral Artery Disease

Intervention / Treatment
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* Device: MARIS-stent (Invatec)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria stent implantation in SFA is possible existing SFA stenosis 70-100 % (visual estimation) absence of homodynamically relevant stenosis in A. poplitea at least one lower limb run off vessel Exclusion criteria pregnancy life expectancy less than 1 year coagulation disorder chronic anticoagulation therapy active gastrointestinal bleeding thrombolytic therapy within 72 hours before intervention hyperthyreosis severe contrast agent allergy allergy to concomittant medication severe liver disease thrombus in target lesion target lesion extend into A. poplitea severe calcification of target vessel, where no successful pre-dilatation is feasible

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: MARIS-stent (Invatec)|stenting of SFA with Maris nitinol stent/s|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| target lesion revascularization |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restenosis rate > 50% according to ultrasound criteria |  | 6 and 12 month | 
| Restenosis rate > 70% according to ultrasound criteria |  | 6 and 12 month | 
| Location of restenosis (proximal, middle, distal AFS) |  | 6 and 12 month | 
| Number of stent fractures (grading according to FESTO criteria) |  | 12 month | 
| Procedure related complication rate |  | Discharge | 
| Vascular complication rate within 12 month |  | 12month | 
| Amputations within 12 month |  | 12month | 
| Deaths within 12 month |  | 12month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nitinol Stent, Superficial femoral artery, SFA, Angioplasty, peripheral artery disease, peripheral artery obstructive disease, PAOD, PAD, Peripheral Vascular Disease