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

This study has been completed.
Information provided by (Responsible Party):
Flanders Medical Research Program Identifier:
First received: October 1, 2008
Last updated: January 24, 2013
Last verified: January 2013
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.

Condition Intervention Phase
Peripheral Vascular Disease Intermittent Claudication Critical Limb Ischemia Device: iliac stenting Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physician Initiated Multi-center Belgian-Italian-Dutch Trial Investigating Abbott Vascular Iliac Stents in the Treatment of TASC A, B, C & D Iliac Lesions

Further study details as provided by Flanders Medical Research Program:

Primary Outcome Measures:
  • 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 [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • Technical success, defined as the ability to achieve final residual angiographic stenosis no greater than 30% [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 1, 6, 12 & 24 months ]
  • Serious adverse events [ Time Frame: 1, 6, 12, 24 months ]

Enrollment: 325
Study Start Date: December 2008
Study Completion Date: December 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stenting Device: iliac stenting
Absolute Pro (Abbott Vascular) or Omnilink Elite (Abbott Vascular) stents


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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 Absolute Pro or Omnilink Elite (Abbott Vascular)


  • 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00764777

Universitair Ziekenhuis Antwerpen
Antwerpen, Belgium
Imelda Hospital
Bonheiden, Belgium, 2820
AZ Sint-Blasius
Dendermonde, Belgium, 9200
ZOL Campus Sint-Jan
Genk, Belgium, 3600
University Hospital
Ghent, Belgium, 9000
Sponsors and Collaborators
Flanders Medical Research Program
Principal Investigator: Marc Bosiers, MD AZ Sint-Blasius, Dendermonde, Belgium
  More Information

Additional Information:
Responsible Party: Flanders Medical Research Program Identifier: NCT00764777     History of Changes
Other Study ID Numbers: FMRP-006
Study First Received: October 1, 2008
Last Updated: January 24, 2013

Keywords provided by Flanders Medical Research Program:
Peripheral Vascular Disease
Intermittent Claudication
Critical limb Ischemia
balloon-expandable stent
Self-expanding stent

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Intermittent Claudication
Pathologic Processes
Cardiovascular Diseases
Arterial Occlusive Diseases
Signs and Symptoms processed this record on September 21, 2017