Misago Iliac Study

Vascular Lesions Clinical Trial

— MISAGO ILIAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01016275
• Other study ID #: FMRP-007
• Status: Completed
• Phase: N/A
• First received: November 18, 2009
• Last updated: August 5, 2014
• Start date: January 2010
• Est. completion date: October 2013

Study information

• Verified date: August 2014
• Source: Flanders Medical Research Program
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Vascular Lesions

Intervention

Device:
• Misago (stent placement)
Misago iliac stent

Locations

Country	Name	City	State
Belgium	Imelda Hospital	Bonheiden	Antwerp
Belgium	AZ Sint-Blasius	Dendermonde	East-Flanders
Belgium	UZ Gent	Gent	East-Flanders
Germany	Herzzentrum Leipzig	Leipzig	Sachsen
Germany	St Franziskus Hospital	Münster	Nordrhein-Westfalen

Sponsors (1)

Lead Sponsor	Collaborator
Flanders Medical Research Program

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 months	No
Secondary	Technical success, defined as the ability to achieve final residual angiographic stenosis no greater than 30%.		procedural	No
Secondary	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.		1 & 24 months	No
Secondary	Clinical success, defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification		1, 12 & 24 months	No
Secondary	Serious adverse events		up to 24 months	No