A Post-market Registry of the MARIS-stent (Invatec) Implanted in the Superficial Femoral Artery (MARIS)
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||MARIS - Prospective, Multicenter Registry|
- target lesion revascularization [ Time Frame: 1 year ]
- Restenosis rate > 50% according to ultrasound criteria [ Time Frame: 6 and 12 month ]
- Restenosis rate > 70% according to ultrasound criteria [ Time Frame: 6 and 12 month ]
- Location of restenosis (proximal, middle, distal AFS) [ Time Frame: 6 and 12 month ]
- Number of stent fractures (grading according to FESTO criteria) [ Time Frame: 12 month ]
- Procedure related complication rate [ Time Frame: Discharge ]
- Vascular complication rate within 12 month [ Time Frame: 12month ]
- Amputations within 12 month [ Time Frame: 12month ]
- Deaths within 12 month [ Time Frame: 12month ]
|Study Start Date:||April 2006|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Device: MARIS-stent (Invatec)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01067885
|Principal Investigator:||Hans Krankenbeg, MD||MCC Prof. Mathey, Prof. Schofer|