Misago Iliac Study (MISAGO ILIAC)

Flanders Medical Research Program

Status: Completed

Conditions: Vascular Lesions

Treatments: Device: Misago (stent placement)

Study type: Observational

Funder types: NETWORK

Identifiers

NCT01016275

FMRP-007

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Iliac lesions TASC A or B

Description:

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

Treatment:

Device: Misago (stent placement)