Drug Eluting Stents In The Critically Ischemic Lower Leg 2

NCT01442636 | Completed Phase 2 DMC

• 1 other identifier: FMRP-101021
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 6

Brief Summary

The objective of this clinical evaluation is to evaluate the immediate and long term (up to 12 months) outcome of the XIENCE PRIME Everolimus Eluting Coronary Stent System (Abbott Vascular) in a controlled prospective investigation for the treatment of patients with critical limb ischemia due to the presence of lesions between 3cm and 10cm in length at the level of the below the knee arteries. Specifically the trial aims to illicit angiographic and ultrasound patency, clinical improvement, and adverse events associated with the use of this stent. The trial design is single armed, prospective, controlled trial run over 12 months of follow-up.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Primary patency at 12 months

  Absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on angiography

  12 months

Secondary Outcomes (8)

• Technical success

  procedure

• Hemodynamic primary patency rate at 1, 6, 12-month follow-up

  1, 6, 12-month follow-up

• Limb-salvage rate at all follow-up visits

  1, 6, 12-month follow-up

• Primary assisted patency rate at 1, 6, 12-month follow-up

  1, 6, 12-month follow-up

• Secondary patency rate at 1, 6, 12-month follow-up

  1, 6, 12-month follow-up

Study Arms (1)

Xience Prime stent

EXPERIMENTAL

Patients with critical limb ischemia due to below the knee arterial lesion between 30 and 100mm in length, treated with the XIENCE PRIME™ Everolimus Eluting Coronary Stent System.

Device: stent

Interventions

stent DEVICE

Implantation of one or more Everolimus-eluting XIENCE PRIME™ Everolimus Eluting Coronary Stent Systems.

Also known as: Xience Prime stent

Xience Prime 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 class 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 the XIENCE PRIME stent (Abbott Vascular)
• 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
• De novo lesion or restenotic lesion after PTA in the infrapopliteal arteries, suitable for endovascular therapy
• Total target lesion length minimally 30mm and maximally 100mm
• Target vessel diameter visually estimated to be \>2.0mm and \<3.5mm
• Guidewire and delivery system successfully traversed lesion

You may not qualify if:

• Patient refusing treatment
• The reference segment diameter is not suitable for the available stent design
• Untreated flow-limiting inflow lesions
• Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
• Any previous surgery in the target vessel (including prior ipsilateral crural bypass)
• Aneurysm in the target vessel
• Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
• Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 1-year life expectancy
• Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
• Septicemia or bacteremia
• Any previously known coagulation disorder, including hypercoagulability
• Contraindication to anticoagulation or antiplatelet therapy
• Known allergies to stent or stent components
• 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

Sponsors & Collaborators

• Flanders Medical Research Program: lead

Study Sites (6)

Prince of Wales Private Hospital

Randwick, New South Wales, 2031, Australia

Location

Imelda Hospital

Bonheiden, Antwerp, 2820, Belgium

Location

Department Vascular Surgery, A.Z. Sint-Blasius Hospital

Dendermonde, East-Flanders, 9200, Belgium

Location

Herz-zentrum Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Herzzentrum

Leipzig, 04289, Germany

Location

St Fransiskus hospital

Münster, 48145, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Stents

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies

Study Officials

• Marc Bosiers, MD

  A.Z. Sint-Blasius Hospital

  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: September 22, 2011
• First Posted: September 28, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2014
• Last Updated: March 9, 2015

Record last verified: 2015-03

Locations

DE (3); BE (2); AU (1)