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

NCT ID: NCT01630070

Last Updated: 2015-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-10-31

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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Self-expandable drug eluting stent

Self-Expanding Paclitaxel-Eluting stent

Group Type: EXPERIMENTAL

Self-expandable drug eluting stent

Intervention Type: DEVICE

Self-Expanding Paclitaxel-Eluting stent

Interventions

Self-expandable drug eluting stent

Self-Expanding Paclitaxel-Eluting stent

Intervention Type: DEVICE

Other Intervention Names

Self-Expanding Paclitaxel-Eluting stent

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Flanders Medical Research Program

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc Bosiers, MD

Role: PRINCIPAL_INVESTIGATOR

AZ Sint-Blasius

Locations

Imelda Hospital

Bonheiden, Antwerp, Belgium

UZA

Edegem, Antwerp, Belgium

RZ Heilig-Hartziekenhuis

Tienen, Antwerp, Belgium

OLV Ziekenhuis

Aalst, East-Flanders, Belgium

AZ Sint-Blasius

Dendermonde, East-Flanders, Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 28351310 (View on PubMed)

Other Identifiers

FMRP-110629

Identifier Type: -

Identifier Source: org_study_id