BeSmooth Study, Investigating the BeSmooth Peripheral Stent System for the Treatment of Iliac Lesions

NCT02690051 | Completed Phase 4 DMC

• 1 other identifier: FMRP-140702
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 4

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Primary Patency at 12 months

  defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (\>50%, systolic velocity ratio no greater than 2.4) and without Target Lesion Revascularization (TLR) within 12 months.

  12 months

Secondary Outcomes (10)

• Primary Patency at 1 & 6 month

  1 and 6 months

• Stent Occlusion Rate at 1,6 and 12-month follow-up

  up to 12 months

• ABI at 1,6 and 12-month follow-up, compared with baseline

  up to 12 months

• Amputation rate at 1,6 and 12-month follow-up

  up to 12 months

• Performance success rate at baseline, defined as restoration of blood flow

  during the index study procedure

Study Arms (1)

BeSmooth Peripheral Stent system

EXPERIMENTAL

Patients treated with the BeSmooth Peripheral Stent System

Device: BeSmooth peripheral stent

Interventions

BeSmooth peripheral stent DEVICE

patients treated with the BeSmooth Peripheral Stent System

BeSmooth Peripheral Stent system

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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 BeGraft Peripheral Stent Graft System (Bentley InnoMed)
• 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

You may not qualify if:

• 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 implantation
• Stenosis distal to the site of stent 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 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)
• 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

Sponsors & Collaborators

• Flanders Medical Research Program: lead

Study Sites (4)

OLV Hospital

Aalst, 9300, Belgium

Location

Imelda Hospital Bonheiden

Bonheiden, 2820, Belgium

Location

AZ Sint-Blasius

Dendermonde, 9200, Belgium

Location

Heilig Hart Hospital

Tienen, 3300, Belgium

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Koen Deloose, MD

  Flanders Medical Research Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 24, 2016
• Study Start: October 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 12, 2017

Record last verified: 2016-02

Locations

BE (4)