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

Peripheral Artery Disease Clinical Trial

— MARIS  

Official title:

MARIS - Prospective, Multicenter Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01067885
• Other study ID #: MARIS-01
• Status: Completed
• Phase: N/A
• First received: February 11, 2010
• Last updated: April 11, 2012
• Start date: April 2006
• Est. completion date: December 2009

Study information

• Verified date: April 2012
• Source: Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1051
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.	Medtronic Vascular

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	target lesion revascularization		1 year	No
Secondary	Restenosis rate > 50% according to ultrasound criteria		6 and 12 month	No
Secondary	Restenosis rate > 70% according to ultrasound criteria		6 and 12 month	No
Secondary	Location of restenosis (proximal, middle, distal AFS)		6 and 12 month	No
Secondary	Number of stent fractures (grading according to FESTO criteria)		12 month	No
Secondary	Procedure related complication rate		Discharge	No
Secondary	Vascular complication rate within 12 month		12month	No
Secondary	Amputations within 12 month		12month	No
Secondary	Deaths within 12 month		12month	No