Clinical trial NCT01630070: Single Arm Study With a Nitinol Self-Expanding Paclitaxel-Eluting Stent to Treat BTK Arteries
Official title: A Prospective, Multi-center, Single Arm Study With a Nitinol Self-Expanding Paclitaxel-Eluting Stent in the Treatment of Atherosclerotic Tibial-peroneal Arteries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Peripheral Arterial Disease
Keywords: Critical limb ischemia
Rest pain
Minor tissue loss
Below the knee
Lead sponsor: Flanders Medical Research Program
Sponsor class: NETWORK
First posted: 2012-06-28
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 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Primary patency
timeFrame: 6 months
measure: Primary patency
timeFrame: 12 months
Secondary outcomes:
measure: Technical success
timeFrame: procedure (day 0)
measure: Procedural success
timeFrame: Procedure (day 0)
measure: MAE (Major Adverse Event)
timeFrame: 1, 6 and 12 months
measure: SAE (Serious Adverse Event)
timeFrame: discharge, 1, 6 and 12 months
measure: Improvement of Rutherford classification
timeFrame: 12 months
measure: Improvement in Ankle-Brachial Index
timeFrame: 12 months
measure: Primary Patency
timeFrame: 1 and 12 months
measure: Secondary patency
timeFrame: 1, 6 and 12 months
measure: Limb salvage rate
timeFrame: Procedure, 1, 6 and 12 months
measure: Target Lesion Revascularisation
timeFrame: Procedure (day 0), 1, 6 and 12 months
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Hospital
state: Antwerp
city: Edegem
country: Belgium
facility: UZA
state: Antwerp
city: Tienen
country: Belgium
facility: RZ Heilig-Hartziekenhuis
state: Antwerp
city: Aalst
country: Belgium
facility: OLV Ziekenhuis
state: East-Flanders
city: Dendermonde
country: Belgium
facility: AZ Sint-Blasius
state: East-Flanders
Study officials:
affiliation: AZ Sint-Blasius
name: Marc Bosiers, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.