Vascular Lesions
Conditions
Keywords
To obtain the first iliac long-term results for a patient cohort treated with nitinol stents only
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.
Interventions
DEVICEMisago (stent placement)
Misago iliac stent
Sponsors
Flanders Medical Research Program
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Belgium, Germany
Outcome results
None listed