Misago Iliac Study

NCT ID: NCT01016275

Last Updated: 2014-08-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2013-10-31

Brief 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.

Conditions

Vascular Lesions

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Iliac lesions TASC A or B

All lesion types belonging to the iliac TASC A or B.

Misago (stent placement)

Intervention Type: DEVICE

Misago iliac stent

Interventions

Misago (stent placement)

Misago iliac stent

Intervention Type: DEVICE

Other Intervention Names

Misago iliac stent

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Flanders Medical Research Program

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vladimir Borovicanin, MD

Role: STUDY_DIRECTOR

Terumo Europe NV

Locations

Imelda Hospital

Bonheiden, Antwerp, Belgium

AZ Sint-Blasius

Dendermonde, East-Flanders, Belgium

UZ Gent

Ghent, East-Flanders, Belgium

St Franziskus Hospital

Münster, North Rhine-Westphalia, Germany

Herzzentrum Leipzig

Leipzig, Saxony, Germany

Countries

Belgium; Germany

Other Identifiers

FMRP-007

Identifier Type: -

Identifier Source: org_study_id