Overview

This trial is active, not recruiting.

Condition peripheral arterial disease
Treatment besmooth peripheral stent
Phase phase 4
Sponsor Flanders Medical Research Program
Start date October 2014
End date November 2016
Trial size 70 participants
Trial identifier NCT02690051, FMRP-140702

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients treated with the BeSmooth Peripheral Stent System
besmooth peripheral stent
patients treated with the BeSmooth Peripheral Stent System

Primary Outcomes

Measure
Primary Patency at 12 months
time frame: 12 months

Secondary Outcomes

Measure
Primary Patency at 1 & 6 month
time frame: 1 and 6 months
Stent Occlusion Rate at 1,6 and 12-month follow-up
time frame: up to 12 months
ABI at 1,6 and 12-month follow-up, compared with baseline
time frame: up to 12 months
Amputation rate at 1,6 and 12-month follow-up
time frame: up to 12 months
Performance success rate at baseline, defined as restoration of blood flow
time frame: during the index study procedure
In-stent restenosis rate
time frame: up to 12 months
Freedom from Target Lesion Revascularization
time frame: up to 12 months
Serious Adverse Events
time frame: up to 12 months
Technical success
time frame: during the index study procedure
Clinical success at follow-up is defined as an improvement of Rutherford Classification at 1-,6- and 12-month follow-up
time frame: up to 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title BeSmooth Study, a Physician-initiated PMCF Trial Investigating the BeSmooth Peripheral Stent System for the Treatment of Iliac Lesions
Principal investigator Marc Bosiers, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Flanders Medical Research Program.