Misago Iliac Study

NCT01016275 | Completed DMC

• 1 other identifier: FMRP-007
• Study Type: observational
• Target: 100
• Locations: 2 countries
• Sites: 5

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

Keywords

To obtain the first iliac long-term results for a patient cohort treated with nitinol stents only

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (4)

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

  procedural

• 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

• 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

• Serious adverse events

  up to 24 months

Study Arms (1)

Iliac lesions TASC A or B

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

Device: Misago (stent placement)

Interventions

Misago (stent placement) DEVICE

Misago iliac stent

Also known as: Misago iliac stent

Iliac lesions TASC A or B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with peripheral arterial disease, Rutherford 2 to 5.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Flanders Medical Research Program: lead

Study Sites (5)

Imelda Hospital

Bonheiden, Antwerp, 2820, Belgium

Location

AZ Sint-Blasius

Dendermonde, East-Flanders, 9200, Belgium

Location

UZ Gent

Ghent, East-Flanders, 9000, Belgium

Location

St Franziskus Hospital

Münster, North Rhine-Westphalia, 48145, Germany

Location

Herzzentrum Leipzig

Leipzig, Saxony, 04289, Germany

Location

Study Officials

• Vladimir Borovicanin, MD

  Terumo Europe NV

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2009
• First Posted: November 19, 2009
• Study Start: January 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2013
• Last Updated: August 6, 2014

Record last verified: 2014-08

Locations

DE (2); BE (3)