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

Critical Limb Ischemia Clinical Trial

— BRAVISSIMO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764777
• Other study ID #: FMRP-006
• Status: Completed
• Phase: Phase 4
• First received: October 1, 2008
• Last updated: January 24, 2013
• Start date: December 2008
• Est. completion date: December 2012

Study information

• Verified date: January 2013
• Source: Flanders Medical Research Program
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review BoardItaly: Ethics CommitteeNetherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: December 2012
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Intermittent Claudication
• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• iliac stenting
Absolute Pro (Abbott Vascular) or Omnilink Elite (Abbott Vascular) stents

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Antwerpen
Belgium	Imelda Hospital	Bonheiden
Belgium	AZ Sint-Blasius	Dendermonde
Belgium	ZOL Campus Sint-Jan	Genk
Belgium	University Hospital	Ghent

Sponsors (1)

Lead Sponsor	Collaborator
Flanders Medical Research Program

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Technical success, defined as the ability to achieve final residual angiographic stenosis no greater than 30%		Procedure	No
Secondary	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	No
Secondary	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	No
Secondary	Serious adverse events		1, 6, 12, 24 months	Yes

External Links

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