Misago Iliac Study (MISAGO ILIAC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Flanders Medical Research Program
ClinicalTrials.gov Identifier:
NCT01016275
First received: November 18, 2009
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Vascular Lesions
Device: Misago (stent placement)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Physician Initiated Multi-center Belgian-German Trial Investigating the Terumo Misago Stent in the Treatment of TASC A & B Iliac Lesions

Further study details as provided by Flanders Medical Research Program:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Technical success, defined as the ability to achieve final residual angiographic stenosis no greater than 30%. [ Time Frame: procedural ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 1 & 24 months ] [ Designated as safety issue: No ]
  • Clinical success, defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification [ Time Frame: 1, 12 & 24 months ] [ Designated as safety issue: No ]
  • Serious adverse events [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2010
Study Completion Date: October 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Iliac lesions TASC A or B
All lesion types belonging to the iliac TASC A or B.
Device: Misago (stent placement)
Misago iliac stent
Other Name: Misago iliac stent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with peripheral arterial disease, Rutherford 2 to 5.

Criteria

Inclusion Criteria:

  • 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)
  • 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

Exclusion Criteria:

  • 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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01016275

Locations
Belgium
Imelda Hospital
Bonheiden, Antwerp, Belgium, 2820
AZ Sint-Blasius
Dendermonde, East-Flanders, Belgium, 9200
UZ Gent
Gent, East-Flanders, Belgium, 9000
Germany
St Franziskus Hospital
Münster, Nordrhein-Westfalen, Germany, 48145
Herzzentrum Leipzig
Leipzig, Sachsen, Germany, 04289
Sponsors and Collaborators
Flanders Medical Research Program
Investigators
Study Director: Vladimir Borovicanin, MD Terumo Europe NV
  More Information

No publications provided

Responsible Party: Flanders Medical Research Program
ClinicalTrials.gov Identifier: NCT01016275     History of Changes
Other Study ID Numbers: FMRP-007
Study First Received: November 18, 2009
Last Updated: August 5, 2014
Health Authority: Belgium: Institutional Review Board

Keywords provided by Flanders Medical Research Program:
To obtain the first iliac long-term results for a patient cohort treated with nitinol stents only

ClinicalTrials.gov processed this record on October 29, 2014