Clinical trial NCT03349996: Belgian Trial Investigating the LifeStream Stent in Complex TASC C and D Iliac Lesions
Official title: Belgian Physician-initiated Trial Investigating the LifeStream Peripheral Stent Graft System for the Treatment of Complex TASC C and D Iliac Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: ID3 Medical
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The BELSTREAM Trial investigates the efficacy of the LifeStream Peripheral Stent Graft System in the treatment of iliac stenotic or occlusive lesions (TASC C and D). An expected total of 70 patients will be treated. The lesion is located within the native Iliac arteries. Prior to stenting with the LifeStream Peripheral Stent Graft System, pre-dilatation can be performed according to the physician's discretion. Also post-dilatation can be performed according to the physician's discretion. Patients will be invited for a follow-up visit at 1, 6, 12, 24 ,36 ,48 and 60-month post-procedure. .The primary efficacy endpoint of the study is the primary patency at 12 months. The primary safety endpoint is the freedom of periprocedural Serious Adverse Events (SAEs). Secondary endpoint include primary patency rate at 1 ,6 ,24 ,36 ,48 and 60 month, stent graft occlusion rate at pre-discharge, 1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up, anke-brachial index (ABI) at 1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up, amputation rate at 1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up, technical success and clinical success at 1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up.

Detailed description: The objective of this clinical investigation is to evaluate, in a controlled setting, the long-term safety and efficacy of the LifeStream Peripheral Stent Graft System in clinical settings post CE-certification when used according to the indications of the IFU with focus on the treatment of complex TASC C and D iliac lesions.

Patients will be selected based on the investigator's assessment, evaluation of the underlying disease and the eligibility criteria. The patient's medical condition should be stable, with no underlying medical condition which would prevent them from performing the required testing or from completing the study. Patients should also be geographically stable, willing and able to cooperate in this clinical study and remain available for long-term follow-up. A patient is considered enrolled in the study after obtaining the patients informed consent, if there is full compliance with the study eligibility criteria and after successful guidewire passage through the study target lesion.

Prior to the index procedure the following tests and clinical data will be collected: informed consent for data collection, demographics, medical history, medication record, physical examination, clinical category of chronic limb ischemia (Rutherford category) and resting ankle-brachial index (ABI).

During the procedure, the vascular access can be achieved to the investigator's standard clinical practice. After successful lesion passage, diagnostic angiography of the lesion area and distal run-off is performed and angiographic measurements (vessel diameter, percentage stenosis and lesion length) are collected. At the physician's discretion, the patient receives at least 1 LifeStream Peripheral Stent Graft System. Pre- and post-dilatation are according to the physician's discretion. No other adjunctive therapies (atherectomy, laser) are allowed. The complete iliac vasculature should be treated in one single session, staged interventions are not allowed. All outflow-limiting lesions must be treated according to the hospital treatment standard.

The regular follow-ups are necessary to monitor the condition of the patient and the stent/procedure. Patients will be invited for a follow-up visit at 1 ,6 ,12 ,24 ,36 ,48 and 60-months after the index procedure. The following data will be collected during these follow-up visit: medication record, physical examination, rutherford categorization, ABI and color flow doppler ultrasound.

Eligibility criteria: General inclusion criteria:

* Corresponding to the CE-mark indications/contra-indications and according to the current medical guidelines for minimally invasive peripheral interventions.
* 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 4 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 Lifestream Peripheral Stent Graft System (Bard)

Angiographic inclusion criteria

* The target lesion is either a modified TASC-II class C or D lesion with one of the listed specifications:

  * Type C lesions

    * Bilateral Common Iliac Artery occlusions
    * Bilateral External Iliac Artery stenoses 3-10 cm long not extending into the Common Femoral Artery
  * Type D lesions

    * Unilateral occlusions of both Common Iliac and External Iliac Artery
    * Diffuse disease involving the aorta bifurcation
    * Bilateral occlusions of External Iliac Artery
* The target lesion has angiographic evidence of stenosis or restenosis post percutaneous transluminal angioplasty (PTA) \> 50% or occlusion which can be passed with standard guidewire manipulation
* There is angiographic evidence of a patent Common and Deep Femoral Artery

Exclusion criteria:

* PTA is technically not possible (not feasible to access the lesion or a defect with the guidewire or balloon catheter)
* Presence of an aneurysm immediately adjacent to the site of stent graft implantation
* Lesions in or adjacent to essential collaterals(s)
* Lesions in locations subject to external compression
* Heavily calcified lesions resistant to PTA
* Patients with diffuse distal disease resulting in poor stent graft outflow
* Patients with a history of coagulation disorders
* Patients with aspirin allergy or bleeding complications and patients unable or unwilling to tolerate anticoagulant/antiplatelet therapy and/or non-responders to anticoagulant/antiplatelet therapy
* Fresh thrombus formation
* Patients with known hypersensitivity to the stent material (L605) and or polytetrafluroethylene (PTFE)
* The target lesion is either a modified TASC-II class C or D lesion with aortic or common femoral lesion involvement:

  * Type C lesions

    * 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 involvement of the Common Femoral Artery
  * 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
    * Diffuse multiple stenoses involving the unilateral Common Iliac, External Iliac and Common Femoral Artery
* Previously implanted stent(s) at the same lesion site
* Reference segment diameter is not suitable for the available stent graft design
* Untreatable lesion located at the distal outflow arteries
* Use of alternative therapy (e.g. atherectomy, cutting balloon, drug coated balloon (DCB), laser, radiation therapy) as part of the index procedure
* Patients refusing treatment
* Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
* Perforation at the angioplasty site evidenced by extravasation of contrast medium
* Patients with a history of prior life-threatening contrast medium reaction
* 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

Primary outcomes:
measure: Primary patency at 12 months
timeFrame: 12 months
measure: Freedom from periprocedural Serious Adverse events (SAEs)
timeFrame: During index procedure
Secondary outcomes:
measure: Primary patency at 1 ,6 ,24 ,36 ,48 and 60- months post procedure
timeFrame: 1 ,6 ,24 ,36 ,48 and 60-months post-procedure
measure: Stent graft occlusion rate
timeFrame: Pre-discharge,1 ,6 ,12 ,24 ,36 ,48 and 60-month follow-up
measure: Ankle-Brachial index (ABI)
timeFrame: 1 ,6 ,12 ,24 ,36 ,48 and 60-month post-procedure
measure: Amputation rate
timeFrame: 1 ,6 ,12 ,24 ,36 ,48 and 60-months post-procedure
measure: Technical success
timeFrame: Index procedure
measure: Clinical success
timeFrame: 1 ,6 ,12 ,24 ,36 ,48 and 60-months post-procedure
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: O.L.V. Hospital
city: Antwerpen
country: Belgium
facility: Z.N.A.
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Dendermonde
country: Belgium
facility: A.Z. Sint-Blasius
city: Genk
country: Belgium
facility: Z.O.L.
city: Kortrijk
country: Belgium
facility: Az Groeninge
city: Tienen
country: Belgium
facility: R.Z. Heilig Hart
Study officials:
affiliation: ID3 Medical
name: Koen Deloose, MD
role: STUDY_DIRECTOR
References: