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

NCT ID: NCT00764777

Last Updated: 2013-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 325 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2012-12-31

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.

Conditions

Peripheral Vascular Disease; Intermittent Claudication; Critical Limb Ischemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stenting

Group Type: EXPERIMENTAL

iliac stenting

Intervention Type: DEVICE

Absolute Pro (Abbott Vascular) or Omnilink Elite (Abbott Vascular) stents

Interventions

iliac stenting

Absolute Pro (Abbott Vascular) or Omnilink Elite (Abbott Vascular) stents

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Flanders Medical Research Program

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Bosiers, MD

Role: PRINCIPAL_INVESTIGATOR

AZ Sint-Blasius, Dendermonde, Belgium

Locations

Universitair Ziekenhuis Antwerpen

Antwerp, , Belgium

Imelda Hospital

Bonheiden, , Belgium

AZ Sint-Blasius

Dendermonde, , Belgium

ZOL Campus Sint-Jan

Genk, , Belgium

University Hospital

Ghent, , Belgium

Countries

Belgium

Other Identifiers

FMRP-006

Identifier Type: -

Identifier Source: org_study_id