Peripheral Artery DiseaseMARISNCT01067885
A Post-market Registry of the MARIS-stent (Invatec) Implanted in the Superficial Femoral Artery
A study testing MARIS-stent (Invatec) in people with Peripheral Artery Disease, run by Medical Care Center Prof. Mathey, Prof. Schofer, Ltd..
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- MARIS-stent (Invatec)
- Type of treatment
- Medical device
- How many people
- 1,051 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- pregnancy
- life expectancy less than 1 year
- coagulation disorder
- chronic anticoagulation therapy
- active gastrointestinal bleeding
- thrombolytic therapy within 72 hours before intervention
Show all 13Show fewer
- 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
About this study
Official title: MARIS - Prospective, Multicenter Registry
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.
Read the 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.
- Conditions
- Peripheral Artery Disease
- Being tested
- MARIS-stent (Invatec)
- Keywords
- Nitinol Stent, Superficial femoral artery, SFA, Angioplasty, peripheral artery disease, peripheral artery obstructive disease, PAOD, PAD, Peripheral Vascular Disease
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MARIS-stent (Invatec)Device
Also called Maris nitinol stent (Invatec, Italy)
stenting of SFA with Maris nitinol stent/s
What is being measured
The primary outcome is the main question the study is designed to answer.
target lesion revascularization
Measured: 1 year
Secondary outcomes (8)
Restenosis rate > 50% according to ultrasound criteria
Measured: 6 and 12 month
Restenosis rate > 70% according to ultrasound criteria
Measured: 6 and 12 month
Location of restenosis (proximal, middle, distal AFS)
Measured: 6 and 12 month
Number of stent fractures (grading according to FESTO criteria)
Measured: 12 month
Procedure related complication rate
Measured: Discharge
Vascular complication rate within 12 month
Measured: 12month
Amputations within 12 month
Measured: 12month
Deaths within 12 month
Measured: 12month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startApr 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,051 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic Vascular
- Responsible party
- Sponsor
- Investigators
- Hans Krankenbeg, MD, Principal investigator, MCC Prof. Mathey, Prof. Schofer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067885
- Sponsor's protocol ID
- MARIS-01
- Acronym
- MARIS
- Status last verified
- Apr 2012
- First submitted
- 11 Feb 2010
- Last updated
- 12 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25101571
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MARIS - Prospective, Multicenter Registry
- ClinicalTrials.gov ID
- NCT01067885
- Acronym / sponsor ID
- MARIS / MARIS-01
- Conditions
- Peripheral Artery Disease
- Keywords
- Nitinol Stent, Superficial femoral artery, SFA, Angioplasty, peripheral artery disease, peripheral artery obstructive disease, PAOD, PAD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,051 participants (actual)
- Lead sponsor
- Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.University, hospital or other
- Collaborators
- Medtronic Vascular
- Study start
- Apr 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 12 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- pregnancy
- life expectancy less than 1 year
- coagulation disorder
- chronic anticoagulation therapy
- active gastrointestinal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MARIS-stent (Invatec)Also: Maris nitinol stent (Invatec, Italy)stenting of SFA with Maris nitinol stent/s | Device | – |
Primary outcome
target lesion revascularization
Time frame: 1 year
8 secondary outcomes
Restenosis rate > 50% according to ultrasound criteria
Time frame: 6 and 12 month
Restenosis rate > 70% according to ultrasound criteria
Time frame: 6 and 12 month
Location of restenosis (proximal, middle, distal AFS)
Time frame: 6 and 12 month
Number of stent fractures (grading according to FESTO criteria)
Time frame: 12 month
Procedure related complication rate
Time frame: Discharge
Vascular complication rate within 12 month
Time frame: 12month
Amputations within 12 month
Time frame: 12month
Deaths within 12 month
Time frame: 12month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2012.
- Derived from this study: PubMed 25101571Krankenberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Krankenbeg, MD principal investigator
MCC Prof. Mathey, Prof. Schofer
Questions about this trial
What is this clinical trial studying?
A study testing MARIS-stent (Invatec) in people with Peripheral Artery Disease, run by Medical Care Center Prof. Mathey, Prof. Schofer, Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
target lesion revascularization (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01067885, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2012.