Clinical trial NCT01067885: A Post-market Registry of the MARIS-stent (Invatec) Implanted in the Superficial Femoral Artery
Official title: MARIS - Prospective, Multicenter Registry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Artery Disease
Keywords: Nitinol Stent
Superficial femoral artery
SFA
Angioplasty
peripheral artery disease
peripheral artery obstructive disease
PAOD
PAD
Peripheral Vascular Disease
Lead sponsor: Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Sponsor class: OTHER
Collaborators: name: Medtronic Vascular
First posted: 2010-02-12
Enrollment: 1051
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: target lesion revascularization
timeFrame: 1 year
Secondary outcomes:
measure: Restenosis rate > 50% according to ultrasound criteria
timeFrame: 6 and 12 month
measure: Restenosis rate > 70% according to ultrasound criteria
timeFrame: 6 and 12 month
measure: Location of restenosis (proximal, middle, distal AFS)
timeFrame: 6 and 12 month
measure: Number of stent fractures (grading according to FESTO criteria)
timeFrame: 12 month
measure: Procedure related complication rate
timeFrame: Discharge
measure: Vascular complication rate within 12 month
timeFrame: 12month
measure: Amputations within 12 month
timeFrame: 12month
measure: Deaths within 12 month
timeFrame: 12month
Other outcomes:
Locations:
Study officials:
affiliation: MCC Prof. Mathey, Prof. Schofer
name: Hans Krankenbeg, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.