A Post-market Registry of the MARIS-stent (Invatec) Implanted in the Superficial Femoral Artery
MARIS
MARIS - Prospective, Multicenter Registry
1 other identifier
interventional
1,051
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2006
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 11, 2010
CompletedFirst Posted
Study publicly available on registry
February 12, 2010
CompletedApril 12, 2012
April 1, 2012
3.7 years
February 11, 2010
April 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
target lesion revascularization
1 year
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Interventions
stenting of SFA with Maris nitinol stent/s
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 25101571DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hans Krankenbeg, MD
MCC Prof. Mathey, Prof. Schofer
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2010
First Posted
February 12, 2010
Study Start
April 1, 2006
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
April 12, 2012
Record last verified: 2012-04