Efficacy Study of Iliac Stents to Treat TASC A-B-C-D Iliac Artery Lesions
Phase 4
Completed
- Conditions
- Peripheral Vascular DiseaseIntermittent ClaudicationCritical Limb Ischemia
- Interventions
- Device: iliac stenting
- Registration Number
- NCT00764777
- Lead Sponsor
- Flanders Medical Research Program
- Brief Summary
The BRAVISSIMO trial wants to investigate in a controlled setting, the long-term (up to 24 months) outcome of the self-expanding nitinol Absolute Pro (Abbott Vascular) and the balloon-expandable Omnilink Elite (Abbott Vascular) stent in TASC A\&B and TASC C\&D iliac lesions. A separate analysis of both patient populations will be performed and listed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 325
Inclusion Criteria
GENERAL
- 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 Absolute Pro or Omnilink Elite (Abbott Vascular)
ANGIOGRAPHIC
- The target lesion is either a modified TASC-II class A, B, C or D 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
- Type C lesions
- Bilateral Common Iliac Artery occlusions
- Bilateral External Iliac Artery stenoses 3-10 cm long not extending into the Common Femoral Artery
- Unilateral External Iliac Artery stenosis extending into the Common Femoral Artery
- Unilateral External Iliac Artery occlusion that involves the origins of the Internal Iliac and/or Common Femoral Artery
- Heavily calcified unilateral External Iliac Artery occlusion with or without involvement of origins of the Internal Iliac and/or Common Femoral Artery
- Type D lesions
- Unilateral occlusions of both Common Iliac and External Iliac Artery
- Diffuse disease involving the aorta and both iliac arteries requiring treatment
- Diffuse multiple stenoses involving the unilateral Common Iliac, External Iliac and Common Femoral Artery
- Bilateral occlusions of External 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 or D lesion with aortic lesion involvement:
- Type B lesions
- Short (≤3 cm) stenosis of infrarenal aorta
- Type D lesions
- Infra-renal aortoiliac occlusion
- Iliac stenoses in patients with an Abdominal Aortic Aneurysm (AAA) requiring treatment and not amenable to endograft placement or other lesions requiring open aortic or iliac surgery
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Stenting iliac stenting -
- Primary Outcome Measures
Name Time Method 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 TLR 12 months
- Secondary Outcome Measures
Name Time Method Technical success, defined as the ability to achieve final residual angiographic stenosis no greater than 30% Procedure Primary patency rate at different follow-up times defined as absence of hemodynamically significant stenosis at the target area on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without prior TLR. 1, 6 & 24 months 3) Clinical success at follow-up is defined as an improvement of Rutherford classification at different follow-ups of one class or more as compared to the pre-procedure Rutherford classification. 1, 6, 12 & 24 months Serious adverse events 1, 6, 12, 24 months
Trial Locations
- Locations (5)
AZ Sint-Blasius
🇧🇪Dendermonde, Belgium
University Hospital
🇧🇪Ghent, Belgium
Imelda Hospital
🇧🇪Bonheiden, Belgium
ZOL Campus Sint-Jan
🇧🇪Genk, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Antwerpen, Belgium