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

NCT01630070 | Completed Phase 2 DMC

• 1 other identifier: FMRP-110629
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 5

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

Keywords

Critical limb ischemia; Rest pain; Minor tissue loss; Below the knee

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Technical success

  procedure (day 0)

• Procedural success

  Procedure (day 0)

• MAE (Major Adverse Event)

  1, 6 and 12 months

• SAE (Serious Adverse Event)

  discharge, 1, 6 and 12 months

• Improvement of Rutherford classification

  12 months

Study Arms (1)

Self-expandable drug eluting stent

EXPERIMENTAL

Self-Expanding Paclitaxel-Eluting stent

Device: Self-expandable drug eluting stent

Interventions

Self-expandable drug eluting stent DEVICE

Self-Expanding Paclitaxel-Eluting stent

Also known as: Self-Expanding Paclitaxel-Eluting stent

Self-expandable drug eluting stent

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Flanders Medical Research Program: lead

Study Sites (5)

Imelda Hospital

Bonheiden, Antwerp, 2820, Belgium

Location

UZA

Edegem, Antwerp, 2650, Belgium

Location

RZ Heilig-Hartziekenhuis

Tienen, Antwerp, 3300, Belgium

Location

OLV Ziekenhuis

Aalst, East-Flanders, 9300, Belgium

Location

AZ Sint-Blasius

Dendermonde, East-Flanders, 9200, Belgium

Location

Related Publications (1)

• 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.

  PMID: 28351310 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Marc Bosiers, MD

  AZ Sint-Blasius

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2012
• First Posted: June 28, 2012
• Study Start: January 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2014
• Last Updated: March 9, 2015

Record last verified: 2015-03

Locations

BE (5)