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

Physician Initiated Multi-center Belgian-Italian-Dutch Trial Investigating Abbott Vascular Iliac Stents in the Treatment of TASC A, B, C & D Iliac Lesions

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.

Study Overview

• Status: Completed
• Conditions: Intermittent Claudication; Peripheral Vascular Disease; Critical Limb Ischemia
• Intervention / Treatment: Device: iliac stenting

• Study Type: Interventional
• Enrollment (Actual): 325
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Antwerpen, Belgium
    • Universitair Ziekenhuis Antwerpen
  • Bonheiden, Belgium, 2820
    • Imelda Hospital
  • Dendermonde, Belgium, 9200
    • AZ Sint-Blasius
  • Genk, Belgium, 3600
    • ZOL Campus Sint-Jan
  • Ghent, Belgium, 9000
    • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stenting	Device: iliac stenting; Absolute Pro (Abbott Vascular) or Omnilink Elite (Abbott Vascular) stents

What is the study measuring?

Primary Outcome Measures

Outcome 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 TLR	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Flanders Medical Research Program
• Investigators: Principal Investigator: Marc Bosiers, MD, AZ Sint-Blasius, Dendermonde, Belgium

Study record dates

Study Major Dates

• Study Start: December 1, 2008
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: October 1, 2008
• First Submitted That Met QC Criteria: October 1, 2008
• First Posted (Estimate): October 2, 2008

Study Record Updates

• Last Update Posted (Estimate): January 25, 2013
• Last Update Submitted That Met QC Criteria: January 24, 2013
• Last Verified: January 1, 2013

More Information

Terms related to this study

• Keywords: Peripheral Vascular Disease; Intermittent Claudication; Critical limb Ischemia; TASC A; TASC B; TASC C; TASC D; balloon-expandable stent; Self-expanding stent; TASC
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Ischemia; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication
• Other Study ID Numbers: FMRP-006