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

Flanders Medical Research Program

Status and phase

Completed

Phase 3

Phase 2

Conditions

Peripheral Arterial Disease

Treatments

Device: Self-expandable drug eluting stent

Study type

Interventional

Funder types

NETWORK

Identifiers

NCT01630070

FMRP-110629

Details and patient eligibility

About

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.

Enrollment

70 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)