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

This study has been completed.
Sponsor:
Collaborator:
Medtronic Vascular
Information provided by (Responsible Party):
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
ClinicalTrials.gov Identifier:
NCT01067885
First received: February 11, 2010
Last updated: April 11, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Peripheral Artery Disease
Device: MARIS-stent (Invatec)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: MARIS - Prospective, Multicenter Registry

Resource links provided by NLM:


Further study details as provided by Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.:

Primary Outcome Measures:
  • target lesion revascularization [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Restenosis rate > 50% according to ultrasound criteria [ Time Frame: 6 and 12 month ] [ Designated as safety issue: No ]
  • Restenosis rate > 70% according to ultrasound criteria [ Time Frame: 6 and 12 month ] [ Designated as safety issue: No ]
  • Location of restenosis (proximal, middle, distal AFS) [ Time Frame: 6 and 12 month ] [ Designated as safety issue: No ]
  • Number of stent fractures (grading according to FESTO criteria) [ Time Frame: 12 month ] [ Designated as safety issue: No ]
  • Procedure related complication rate [ Time Frame: Discharge ] [ Designated as safety issue: No ]
  • Vascular complication rate within 12 month [ Time Frame: 12month ] [ Designated as safety issue: No ]
  • Amputations within 12 month [ Time Frame: 12month ] [ Designated as safety issue: No ]
  • Deaths within 12 month [ Time Frame: 12month ] [ Designated as safety issue: No ]

Enrollment: 1051
Study Start Date: April 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: MARIS-stent (Invatec)
    stenting of SFA with Maris nitinol stent/s
    Other Name: Maris nitinol stent (Invatec, Italy)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01067885

Sponsors and Collaborators
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Medtronic Vascular
Investigators
Principal Investigator: Hans Krankenbeg, MD MCC Prof. Mathey, Prof. Schofer
  More Information

No publications provided

Responsible Party: Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
ClinicalTrials.gov Identifier: NCT01067885     History of Changes
Other Study ID Numbers: MARIS-01
Study First Received: February 11, 2010
Last Updated: April 11, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.:
Nitinol Stent
Superficial femoral artery
SFA
Angioplasty
peripheral artery disease
peripheral artery obstructive disease
PAOD
PAD
Peripheral Vascular Disease

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014