Clinical trial NCT02690051: BeSmooth Study, Investigating the BeSmooth Peripheral Stent System for the Treatment of Iliac Lesions
Official title: BeSmooth Study, a Physician-initiated PMCF Trial Investigating the BeSmooth Peripheral Stent System for the Treatment of Iliac Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Arterial Disease
Lead sponsor: Flanders Medical Research Program
Sponsor class: NETWORK
First posted: 2016-02-24
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: A Physician initiated PMCF Trial Investigating the BeSmooth Peripheral Stent System for the treatment of Iliac Lesions.

The objective of this clinical investigation is to evaluate the long-term safety and efficacy of the BeSmooth Peripheral Stent System in clinical settings post CE-certification when used according to the indications of the IFU.


Eligibility criteria: Inclusion Criteria:

1. Corresponding to the CE-mark indications/contra-indications and according to the current medical guidelines for minimally invasive peripheral interventions.
2. 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)
3. Patient presenting a score from 2 to 5 following Rutherford classification
4. Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study
5. Patient is \>18 years old
6. Patient (or their legal representative) understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
7. Patient is eligible for treatment with the BeGraft Peripheral Stent Graft System (Bentley InnoMed)
8. 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
9. The target lesion has angiographic evidence of stenosis or restenosis \> 50% or occlusion which can be passed with standard guidewire manipulation
10. There is angiographic evidence of a patent Common an Deep Femoral Artery

Exclusion Criteria:

1. PTA is technically not possible (not feasible to access the lesion or a defect with the guidewire or balloon catheter)
2. Presence of an aneurysm immediately adjacent to the site of stent implantation
3. Stenosis distal to the site of stent implantation
4. Lesions in or adjacent to essential collaterals(s)
5. Lesions in locations subject to external compression
6. Heavily calcified lesions resistant to PTA
7. Patients with diffuse distal disease resulting in poor stent outflow
8. Patients with a history of coagulation disorders
9. 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
10. Fresh thrombus formation
11. Patients with known hypersensitivity to the stent material(L605)
12. The target lesion is either a modified TASC-II class B or D lesion with aortic or common femoral lesion involvement:

    * Type B lesions

      -Short (≤3 cm) stenosis of infrarenal aorta
    * 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 or without involvement of origins of the Internal Iliac and/or 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
      * Unilateral occlusions of both Common Iliac and External Iliac Artery
      * Diffuse disease involving the aorta and both iliac arteries requiring treatment
      * Bilateral occlusions of the External Iliac Artery
13. Previously implanted stent(s) at the same lesion site
14. Reference segment diameter is not suitable for the available stent design
15. Untreatable lesion located at the distal outflow arteries
16. Use of alternative therapy (e.g. atherectomy, cutting balloon, laser, radiation therapy) as part of the index procedure
17. Patients refusing treatment
18. Patients for whom antiplatelet therapy, anticoagulants or thrombolytic drugs are contraindicated
19. Patients who exhibit persistent acute intraluminal thrombus of the proposed lesion site
20. Perforation at the angioplasty site evidenced by extravasation of contrast medium
21. Patients with a history of prior life-threatening contrast medium reaction
22. Patients with uncorrected bleeding disorders
23. Female patient with child bearing potential not taking adequate contraceptives or currently breastfeeding
24. Life expectancy of less than twelve months
25. Any planned surgical intervention/procedure within 30 days of the study procedure
26. Any patient considered to be hemodynamically unstable at onset of procedure
27. 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 at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Primary Patency at 1 & 6 month
timeFrame: 1 and 6 months
measure: Stent Occlusion Rate at 1,6 and 12-month follow-up
timeFrame: up to 12 months
measure: ABI at 1,6 and 12-month follow-up, compared with baseline
timeFrame: up to 12 months
measure: Amputation rate at 1,6 and 12-month follow-up
timeFrame: up to 12 months
measure: Performance success rate at baseline, defined as restoration of blood flow
timeFrame: during the index study procedure
measure: In-stent restenosis rate
timeFrame: up to 12 months
measure: Freedom from Target Lesion Revascularization
timeFrame: up to 12 months
measure: Serious Adverse Events
timeFrame: up to 12 months
measure: Technical success
timeFrame: during the index study procedure
measure: Clinical success at follow-up is defined as an improvement of Rutherford Classification at 1-,6- and 12-month follow-up
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Hospital
city: Bonheiden
country: Belgium
facility: Imelda Hospital Bonheiden
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
city: Tienen
country: Belgium
facility: Heilig Hart Hospital
Study officials:
affiliation: Flanders Medical Research Program
name: Koen Deloose, MD
role: PRINCIPAL_INVESTIGATOR
References: