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

NCT00764777 | Completed Phase 4

• 1 other identifier: FMRP-006
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 5

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

Keywords

Peripheral Vascular Disease; Intermittent Claudication; Critical limb Ischemia; TASC A; TASC B; TASC C; TASC D; balloon-expandable stent; Self-expanding stent; TASC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

Stenting

EXPERIMENTAL

Device: iliac stenting

Interventions

iliac stenting DEVICE

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

Stenting

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Flanders Medical Research Program: lead

Study Sites (5)

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium

Location

Imelda Hospital

Bonheiden, 2820, Belgium

Location

AZ Sint-Blasius

Dendermonde, 9200, Belgium

Location

ZOL Campus Sint-Jan

Genk, 3600, Belgium

Location

University Hospital

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases; Intermittent Claudication; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Peripheral Arterial Disease; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Ischemia

Study Officials

• Marc Bosiers, MD

  AZ Sint-Blasius, Dendermonde, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2008
• First Posted: October 2, 2008
• Study Start: December 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: December 1, 2012
• Last Updated: January 25, 2013

Record last verified: 2013-01

Locations

BE (5)