A Post-market Registry of the MARIS-stent (Invatec) Implanted in the Superficial Femoral Artery (MARIS)
Primary Purpose
Peripheral Artery Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MARIS-stent (Invatec)
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Artery Disease focused on measuring Nitinol Stent, Superficial femoral artery, SFA, Angioplasty, peripheral artery disease, peripheral artery obstructive disease, PAOD, PAD, Peripheral Vascular Disease
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
target lesion revascularization
Secondary Outcome Measures
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
Full Information
NCT ID
NCT01067885
First Posted
February 11, 2010
Last Updated
April 11, 2012
Sponsor
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Collaborators
Medtronic Vascular
1. Study Identification
Unique Protocol Identification Number
NCT01067885
Brief Title
A Post-market Registry of the MARIS-stent (Invatec) Implanted in the Superficial Femoral Artery
Acronym
MARIS
Official Title
MARIS - Prospective, Multicenter Registry
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Collaborators
Medtronic Vascular
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
Keywords
Nitinol Stent, Superficial femoral artery, SFA, Angioplasty, peripheral artery disease, peripheral artery obstructive disease, PAOD, PAD, Peripheral Vascular Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1051 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
MARIS-stent (Invatec)
Other Intervention Name(s)
Maris nitinol stent (Invatec, Italy)
Intervention Description
stenting of SFA with Maris nitinol stent/s
Primary Outcome Measure Information:
Title
target lesion revascularization
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Restenosis rate > 50% according to ultrasound criteria
Time Frame
6 and 12 month
Title
Restenosis rate > 70% according to ultrasound criteria
Time Frame
6 and 12 month
Title
Location of restenosis (proximal, middle, distal AFS)
Time Frame
6 and 12 month
Title
Number of stent fractures (grading according to FESTO criteria)
Time Frame
12 month
Title
Procedure related complication rate
Time Frame
Discharge
Title
Vascular complication rate within 12 month
Time Frame
12month
Title
Amputations within 12 month
Time Frame
12month
Title
Deaths within 12 month
Time Frame
12month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Krankenbeg, MD
Organizational Affiliation
MCC Prof. Mathey, Prof. Schofer
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
25101571
Citation
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.
Results Reference
derived
Learn more about this trial
A Post-market Registry of the MARIS-stent (Invatec) Implanted in the Superficial Femoral Artery
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