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

MARIS - Prospective, Multicenter Registry

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease
• Intervention / Treatment: Device: MARIS-stent (Invatec)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 1051
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
target lesion revascularization	1 year

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
• Collaborators: Medtronic Vascular
• Investigators: Principal Investigator: Hans Krankenbeg, MD, MCC Prof. Mathey, Prof. Schofer

Publications and helpful links

General Publications

• Krankenberg H, Tubler T, Sixt S, Fischer M, Schmiedel R, Schulte KL, Balzer JO, Kieback A, Fiehn E, Wittenberg G, Ali T, Tiefenbacher C, Jahnke T, Steinkamp HJ, Wegscheider K, Treszl A, Ingwersen M, Zeller T. German multicenter real-world registry of stenting for superficial femoral artery disease: clinical results and predictive factors for revascularization. J Endovasc Ther. 2014 Aug;21(4):463-71. doi: 10.1583/13-4625R.1.

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: February 11, 2010
• First Submitted That Met QC Criteria: February 11, 2010
• First Posted (Estimate): February 12, 2010

Study Record Updates

• Last Update Posted (Estimate): April 12, 2012
• Last Update Submitted That Met QC Criteria: April 11, 2012
• Last Verified: April 1, 2012

More Information

Terms related to this study

• Keywords: PAD; Peripheral Vascular Disease; Angioplasty; peripheral artery disease; SFA; PAOD; Superficial femoral artery; Nitinol Stent; peripheral artery obstructive disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Vascular Diseases; Peripheral Arterial Disease
• Other Study ID Numbers: MARIS-01