Clinical trial NCT01016275: Misago Iliac Study
Official title: Physician Initiated Multi-center Belgian-German Trial Investigating the Terumo Misago Stent in the Treatment of TASC A & B Iliac Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Lesions
Keywords: To obtain the first iliac long-term results for a patient cohort treated with nitinol stents only
Lead sponsor: Flanders Medical Research Program
Sponsor class: NETWORK
First posted: 2009-11-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with peripheral arterial disease, Rutherford 2 to 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.


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.

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: Technical success, defined as the ability to achieve final residual angiographic stenosis no greater than 30%.
timeFrame: procedural
measure: 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.
timeFrame: 1 & 24 months
measure: Clinical success, defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification
timeFrame: 1, 12 & 24 months
measure: Serious adverse events
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Hospital
state: Antwerp
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
state: East-Flanders
city: Gent
country: Belgium
facility: UZ Gent
state: East-Flanders
city: Münster
country: Germany
facility: St Franziskus Hospital
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig
state: Sachsen
Study officials:
affiliation: Terumo Europe NV
name: Vladimir Borovicanin, MD
role: STUDY_DIRECTOR
References: