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Vascular LesionsMISAGO ILIACNCT01016275

Misago Iliac Study

An observational study of Vascular Lesions, run by Flanders Medical Research Program at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this clinical study is to evaluate, in a controlled setting, the long-term (up to 24 months) outcome of the self-expanding nitinol rapid-exchange Misago (Terumo) stent in TASC A and B iliac lesions. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Vascular Lesions
What is being tested?
Misago (stent placement)
Type of treatment
Medical device
How many people
100 participants
Where
5 sitesin 2 countries
Study dates
Jan 2010to Oct 2013
Phase
Observational
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

Study population: Patients with peripheral arterial disease, Rutherford 2 to 5.

Who may be able to join

  • Patient presenting with a stenotic or occlusive lesion at the iliac arteries suitable for stenting (on indication for primary stenting, based on the discretion of the investigator)
  • Patient presenting a score from 2 to 5 following Rutherford classification
  • Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study
  • Patient is >18 years old
  • Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
  • Patient is eligible for treatment with the Misago (Terumo)
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  • The target lesion is either a modified TASC-II class A or B lesion with one of the listed specifications:
  • Type A lesions
  • Unilateral or bilateral stenoses of the Common Iliac Artery
  • Unilateral or bilateral single short (≤3 cm) stenosis of the External Iliac Artery
  • Type B lesions
  • Unilateral Common Iliac Artery occlusion
  • Single or multiple stenosis totaling 3-10 cm involving the External Iliac Artery not extending into the Common Femoral Artery
  • Unilateral External Iliac Artery occlusion not involving the origins of Internal Iliac Artery or Common Iliac Artery
  • The target lesion has angiographic evidence of stenosis or restenosis > 50% or occlusion which can be passed with standard guidewire manipulation
  • There is angiographic evidence of a patent Common an Deep Femoral Artery

Who cannot join

  • The target lesion is either a modified TASC-II class B lesion with aortic lesion involvement:
  • Short (≤3 cm) stenosis of infrarenal aorta
  • The target lesion is either a modified TASC-II class C or D lesion with aortic lesion involvement:
  • Presence of aneurysm at the level of the iliac arteries
  • Previously implanted stent(s) at the same lesion site
  • Reference segment diameter is not suitable for available stent design
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  • Untreatable lesion located at the distal outflow arteries
  • Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure
  • Patients refusing treatment
  • Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
  • Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
  • Perforation at the angioplasty site evidenced by extravasation of contrast medium
  • Patients with a history of prior life-threatening contrast medium reaction
  • Patients with known hypersensitivity to nickel-titanium
  • Patients with uncorrected bleeding disorders
  • Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
  • Life expectancy of less than twelve months
  • Any planned surgical intervention/procedure within 30 days of the study procedure
  • Any patient considered to be hemodynamically unstable at onset of procedure
  • Patient is currently participating in another investigational drug or device study that has not completed the entire follow up period.

Trial locations and contacts

5 sites in 2 countries.

5 sites in 2 countries

Belgium3 sites

  • Imelda Hospital

    Bonheiden, Antwerp, 2820

  • AZ Sint-Blasius

    Dendermonde, East-Flanders, 9200

  • UZ Gent

    Ghent, East-Flanders, 9000

Other trials in Belgium

Germany2 sites

  • Herzzentrum Leipzig

    Leipzig, Saxony, 04289

  • St Franziskus Hospital

    Münster, North Rhine-Westphalia, 48145

Other trials in Germany

About this study

Official title: Physician Initiated Multi-center Belgian-German Trial Investigating the Terumo Misago Stent in the Treatment of TASC A & B Iliac Lesions

The objective of this clinical study is to evaluate, in a controlled setting, the long-term (up to 24 months) outcome of the self-expanding nitinol rapid-exchange Misago (Terumo) stent in TASC A and B iliac lesions.

Being tested
Misago (stent placement)
Keywords
To obtain the first iliac long-term results for a patient cohort treated with nitinol stents only

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Misago (stent placement)Device

    Also called Misago iliac stent

    Misago iliac stent

Study groups in NCT01016275
Study groupRoleWhat they receive
Iliac lesions TASC A or BAll lesion types belonging to the iliac TASC A or B.
Receives: Device: Misago (stent placement)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary patency, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without Target Lesion Revascularization (TLR) within 12 months.

    Measured: 12 months

Secondary outcomes (4)

  1. Technical success, defined as the ability to achieve final residual angiographic stenosis no greater than 30%.

    Measured: procedural

  2. Patients that present without a hemodynamically significant stenosis at the target area on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without prior TLR are defined as being primary patent at the given follow-up.

    Measured: 1 & 24 months

  3. Clinical success, defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification

    Measured: 1, 12 & 24 months

  4. Serious adverse events

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionOct 2012
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01016275
Sponsor's protocol ID
FMRP-007
Acronym
MISAGO ILIAC
Status last verified
Aug 2014
First submitted
18 Nov 2009
Last updated
6 Aug 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Vascular Lesions, run by Flanders Medical Research Program at 5 sites in 2 countries.

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 16 inclusion and 20 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 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Primary patency, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without Target Lesion Revascularization (TLR) within 12 months. (time frame: 12 months). 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 NCT01016275.

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 6 Aug 2014.

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