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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Flanders Medical Research Program
ClinicalTrials.gov Identifier:
NCT00764777
First received: October 1, 2008
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764777

Locations
Belgium
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
Investigators
Principal Investigator: Marc Bosiers, MD AZ Sint-Blasius, Dendermonde, Belgium
  More Information

Additional Information:
No publications provided

Responsible Party: Flanders Medical Research Program
ClinicalTrials.gov Identifier: NCT00764777     History of Changes
Other Study ID Numbers: FMRP-006
Study First Received: October 1, 2008
Last Updated: January 24, 2013
Health Authority: Belgium: Institutional Review Board
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Flanders Medical Research Program:
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:
Ischemia
Vascular Diseases
Intermittent Claudication
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Signs and Symptoms
Atherosclerosis

ClinicalTrials.gov processed this record on September 16, 2014