Clinical trial NCT00764777: Efficacy Study of Iliac Stents to Treat TASC A-B-C-D Iliac Artery Lesions
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Flanders Medical Research Program
Sponsor class: NETWORK
First posted: 2008-10-02
Enrollment: 325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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
timeFrame: 12 months
Secondary outcomes:
measure: Technical success, defined as the ability to achieve final residual angiographic stenosis no greater than 30%
timeFrame: Procedure
measure: 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.
timeFrame: 1, 6 & 24 months
measure: 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.
timeFrame: 1, 6, 12 & 24 months
measure: Serious adverse events
timeFrame: 1, 6, 12, 24 months
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
city: Genk
country: Belgium
facility: ZOL Campus Sint-Jan
city: Ghent
country: Belgium
facility: University Hospital
Study officials:
affiliation: AZ Sint-Blasius, Dendermonde, Belgium
name: Marc Bosiers, MD
role: PRINCIPAL_INVESTIGATOR
References: