Single Arm Study With a Nitinol Self-Expanding Paclitaxel-Eluting Stent to Treat BTK Arteries (PES-BTK-70)

A Prospective, Multi-center, Single Arm Study With a Nitinol Self-Expanding Paclitaxel-Eluting Stent in the Treatment of Atherosclerotic Tibial-peroneal Arteries

The objective of this clinical study is to evaluate the immediate and long-term (up to 12 month) safety and effectiveness of a Nitinol Self-Expanding Paclitaxel-Eluting stent for the treatment of patients with critical limb ischemia (i.e. rest pain or non-healing foot ulcers) due to the presence of arterial lesions in the below-the-knee arteries of maximally 50mm long.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Self-expandable drug eluting stent

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Bonheiden, Antwerp, Belgium, 2820
      • Imelda Hospital
    • Edegem, Antwerp, Belgium, 2650
      • UZA
    • Tienen, Antwerp, Belgium, 3300
      • RZ Heilig-Hartziekenhuis
  • East-Flanders
    • Aalst, East-Flanders, Belgium, 9300
      • OLV Ziekenhuis
    • Dendermonde, East-Flanders, Belgium, 9200
      • AZ Sint-Blasius

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient presenting with rest pain or minor tissue loss (Rutherford Clinical Category 4 or 5)
• Patient is willing to comply with specified follow-up evaluations at the specified times
• Patient is >18 years old
• Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
• Patient has a projected life-expectancy of at least 12 months
• Patient is eligible for treatment with a Self-Expanding Paclitaxel-Eluting stent
• Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure
• Evidence at screening of ≥50% de novo lesion (or restenosis after previous PTA) in the infrapopliteal arteries, confirmed by angiography
• Reference vessel diameter visually estimated to be ≥3.0mm and ≤4.5mm
• Identifiable distal target vessel which upon completion of the intervention, is anticipated to provide reconstitution of blood flow to the foot.
• Guidewire successfully traversed lesion
• Length of target lesion is <50mm

Exclusion Criteria:

• Untreated flow-limiting inflow lesions
• Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
• Has had a previous peripheral bypass affecting the target limb
• Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
• Non-atherosclerothic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
• Patient has a contra-indication or known untreated allergy to anti-platelet therapy, anticoagulants, thrombolytic drugs or any other drug anticipated to be used
• Patient has hypersensitivity to contrast or device material that cannot be adequately pretreated
• Patient has known uncontrollable hypercoagulable condition, or refuses blood transfusion
• Life expectancy of less than 12 months
• Patient is currently participating in an investigational drug or another device study that may clinically interfere with the study endpoints
• Patient has other co-morbid condition(s) that in the judgment of the physician precludes safe percutaneous intervention
• Has end-stage renal disease defined as undergoing hemodialysis for kidney failure
• Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
• Patient with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT)type II
• Treatment of ipsilateral non-study inflow lesions with other materials than regular guidewires, regular PTA balloons, bare metal stents and/or paclitaxel-coated stents
• Additional treatments of the study lesion requiring materials/procedures other than standard guidewires, regular PTA balloons and/or a Self-Expanding Paclitaxel-Eluting stent (e.g. thrombectomy, re-entry catheters, CTO-wires, cutting balloon, cryoballoon, etc)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Self-expandable drug eluting stent; Self-Expanding Paclitaxel-Eluting stent	Device: Self-expandable drug eluting stent; Self-Expanding Paclitaxel-Eluting stent; Other Names: Self-Expanding Paclitaxel-Eluting stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary patency	Primary patency rate at 6 months, defined by duplex ultrasound measurement of peak systolic velocity ratio ≤2.0 at the target lesion(s) with no clinically-driven reintervention within the treated segment, verified by Core Lab	6 months
Primary patency	Primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on angiography, verified by Core Lab	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success	Technical success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30% by visual assessment	procedure (day 0)
Procedural success	Procedural success, defined as the ability to achieve <30% final residual stenosis of the target lesion by visual estimation (angio) and the absence of any in-hospital Major Adverse Events (MAE, defined as clinically-driven target vessel revascularization, major unplanned amputation of the treated limb, and all-cause mortality)	Procedure (day 0)
MAE (Major Adverse Event)	MAE at 1, 6 and 12 months Major Adverse Events (MAE) include (but are not limited to); death; myocardial infarction; stroke; emergent surgical revascularization of the target vessel; repeat vascularization of the target vessel; major amputation; bleeding complication requiring transfusion	1, 6 and 12 months
SAE (Serious Adverse Event)	Other SAEs at discharge, 1, 6 and 12 months A Serious Adverse Event (SAE) is defined as an Adverse Event which: results in death; is life-threatening; results in persistent or significant disability/incapacity; requires in-patient hospitalization or unduly prolonged hospitalization.; necessitates an intervention to prevent a permanent impairment of a body function or permanent damage to a body structure.; is a congenital abnormality/birth defect, a fetal distress or fetal death; results in malignancy	discharge, 1, 6 and 12 months
Improvement of Rutherford classification	Improvement in Rutherford Clinical Category at 12 months, defined as an improvement in clinical status indicated by a decrease of one or more in Rutherford Clinical Category at 12 months compared to baseline, that is attributable to the treated limb (in cases of bilateral disease)	12 months
Improvement in Ankle-Brachial Index	Improvement in Ankle-Brachial Index at 12 months, defined as an increase in the ankle-brachial index (ABI) at 1 year compared to baseline in subjects with compressible arteries and baseline ABI<0.9	12 months
Primary Patency	Primary patency rate at 1 and 12 months, defined by duplex ultrasound measurement of peak systolic velocity ratio ≤2.0 at the target lesion(s) with no clinically-driven reintervention within the treated segment	1 and 12 months
Secondary patency	Secondary patency rate at 1, 6 and 12 months, defined by duplex ultrasound peak systolic velocity ratio ≤2.0 maintained by repeat percutaneous intervention	1, 6 and 12 months
Limb salvage rate	Limb salvage rate, defined as 1 minus major amputation rate (major amputation is defined as at or above ankle, as opposed to minor amputation being at or below metatarsus preserving functionality of foot	Procedure, 1, 6 and 12 months
Target Lesion Revascularisation	Target lesion revascularization (TLR), defined as a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge.	Procedure (day 0), 1, 6 and 12 months

Collaborators and Investigators

• Sponsor: Flanders Medical Research Program
• Investigators: Principal Investigator: Marc Bosiers, MD, AZ Sint-Blasius

Publications and helpful links

General Publications

• Bosiers M, Callaert J, Keirse K, Hendriks JMH, Peeters P, Verbist J, Maene L, Beelen R, Deloose K. One-Year Outcomes of the Paclitaxel-Eluting, Self-Expanding Stentys Stent System in the Treatment of Infrapopliteal Lesions in Patients With Critical Limb Ischemia. J Endovasc Ther. 2017 Jun;24(3):311-316. doi: 10.1177/1526602817697319. Epub 2017 Mar 9.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): October 1, 2013
• Study Completion (ACTUAL): October 1, 2014

Study Registration Dates

• First Submitted: June 18, 2012
• First Submitted That Met QC Criteria: June 26, 2012
• First Posted (ESTIMATE): June 28, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): March 9, 2015
• Last Update Submitted That Met QC Criteria: March 6, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Critical limb ischemia; Below the knee; Rest pain; Minor tissue loss
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: FMRP-110629