Efficacy Study of Iliac Stents to Treat TASC A-B-C-D Iliac Artery Lesions (BRAVISSIMO)

Flanders Medical Research Program

Status and phase

Completed

Phase 4

Conditions

Peripheral Vascular Disease

Critical Limb Ischemia

Intermittent Claudication

Treatments

Device: iliac stenting

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT00764777

FMRP-006

Details and patient eligibility

About

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.

Enrollment

325 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.