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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00764777
Recruitment Status : Completed
First Posted : October 2, 2008
Last Update Posted : January 25, 2013
Sponsor:
Information provided by (Responsible Party):
Flanders Medical Research Program

Tracking Information
First Submitted Date  ICMJE October 1, 2008
First Posted Date  ICMJE October 2, 2008
Last Update Posted Date January 25, 2013
Study Start Date  ICMJE December 2008
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 1, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of Iliac Stents to Treat TASC A-B-C-D Iliac Artery Lesions
Official Title  ICMJE Physician Initiated Multi-center Belgian-Italian-Dutch Trial Investigating Abbott Vascular Iliac Stents in the Treatment of TASC A, B, C & D Iliac Lesions
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Peripheral Vascular Disease
  • Intermittent Claudication
  • Critical Limb Ischemia
Intervention  ICMJE Device: iliac stenting
Absolute Pro (Abbott Vascular) or Omnilink Elite (Abbott Vascular) stents
Study Arms  ICMJE Experimental: Stenting
Intervention: Device: iliac stenting
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2013)
325
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2008)
270
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date September 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00764777
Other Study ID Numbers  ICMJE FMRP-006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Flanders Medical Research Program
Study Sponsor  ICMJE Flanders Medical Research Program
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Marc Bosiers, MD AZ Sint-Blasius, Dendermonde, Belgium
PRS Account Flanders Medical Research Program
Verification Date January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP