EXCimEr Laser for Long lENgTh Lesions in Below-The-Knee Arteries Study (EXCELLENT-BTK)

A Physician Initiated Prospective Multicenter Study on Excimer Laser Recanalisation in the Treatment of Long Infrapopliteal Lesions in Patients With Critical Limb Ischemia

This investigation is designed to assess the immediate and long-term angiographic patency outcomes of excimer laser recanalisation followed by PTA in the treatment of long (>50 mm) infrapopliteal lesions in patients with critical limb ischemia (CLI)

The Spectranetics Turbo elite™ excimer laser catheters are percutaneous intravascular devices constructed of multiple optical fibers around a guidewire lumen. The laser catheters transmit ultraviolet energy from the Spectranetics CVX-300® Excimer Laser System to the obstruction in the artery. The ultraviolet energy is delivered to the tip of the laser catheter to photo-ablate fibrous, calcific and atheromatous lesions, thus recanalizing diseased vessels.

Study Overview

• Status: Terminated
• Conditions: Peripheral Arterial Occlusive Disease
• Intervention / Treatment: Device: Spectranetics Turbo elite™ excimer laser catheter

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Bonheiden, Belgium, 2820
    • Imelda Hospital
  • Dendermonde, Belgium, 9200
    • AZ St-Blasius

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The treatment vessel is DeNovo
• Stenotic (>50%) or occlusive atherosclerotic disease of infrapopliteal artery(s)
• Length of target lesion is > 50 mm
• Reference target vessel diameter between 2-4.0 mm by visual assessment
• Documented Rutherford Class 4 or 5 symptomatic critical limb ischemia
• The patient must be >18 years of age
• Life-expectancy of more than 12 months
• The patient has no child bearing potential or negative serum pregnancy test within 7 days of the index procedure
• The patient must be willing and able to return to the appropriate follow-up times for the duration of the study
• The patient must provide written patient informed consent that is approved by the ethics committee

• Anatomic Inclusion Criteria

  • All inflow lesions successfully (<30 residual stenosis) treated prior to target lesion treatment during same procedure or according standard of care without unresolved complications
  • At least one angiographically visible target at the ankle for establishment of straight line flow.

Exclusion Criteria:

• Patient refusing treatment
• The target vessel segment diameter is not suitable for available catheter design.
• Unsuccessfully treated endovascular or bypass( >30% residual stenosis) proximal ( iliac, SFA, popliteal) inflow limiting arterial/graft stenosis
• Lesion lies within or adjacent to an aneurysm
• The patient has a known allergy to heparin, Aspirin or other antiaggregant therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies.
• The patient has a history of prior life-threatening contrast media reaction.
• The patient is currently enrolled in another investigational device or drug trial.
• The patient is currently breast-feeding, pregnant or intends to become pregnant.
• The patient is unable to provide informed consent
• The patient has end stage renal disease (currently on any form of dialysis)
• Known Left Ventricular Ejection Fraction < 35%
• The patient has had an MI within 30 days prior to enrollment
• The patient has had a CVA within 90 days prior to enrollment
• Serum Creatinine > 150 µmol
• The patient has a previous bypass in the target limb
• The patient has a current systemic infection

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 1; CLI patients receiving excimer laser recanalisation for the treatment of long infrapopliteal lesions

Device: Spectranetics Turbo elite™ excimer laser catheter; The Spectranetics Turbo elite™ excimer laser catheters are percutaneous intravascular devices constructed of multiple optical fibers around a guidewire lumen. The laser catheters transmit ultraviolet energy from the Spectranetics CVX-300® Excimer Laser System to the obstruction in the artery. The ultraviolet energy is delivered to the tip of the laser catheter to photo-ablate fibrous, calcific and atheromatous lesions, thus recanalizing diseased vessels.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Angiographic patency for laser + PTA, as defined by < 50% stenosis in the target lesion with straight line flow to the foot	12 months
Absence of Major Adverse Events defined as death, amputation of treated limb and target vessel revascularization	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Immediate angiographic laser recanalization success + PTA, defined as a residual diameter stenosis ≤30% and absence of flow-limiting dissection on visual assessment after combined excimer laser and PTA recanalization treatment	Procedure
Absence of Major Adverse Events defined as death, amputation of treated limb and target vessel revascularization	12 months
Limb-salvage rate at all follow-up visits, defined as lack of major amputation of treated limb. Limb-salvage rate (LSR) is defined as 1 minus major amputation rate	12 months
Serious adverse events defined as being fatal, life-threatening, or judged to be severe by the investigator; result in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged or new hospitalization	12 months
Clinical success at follow-up is defined as an improvement of Rutherford classification of one class or more as compared to the pre-procedure Rutherford classification	12 months
Health Economics assessment being: length of hospital stay, duration of the procedure, unplanned visits, retreatment and diagnostic procedure codes, material and medication costs	12 months

Collaborators and Investigators

• Sponsor: Flanders Medical Research Program
• Collaborators: Spectranetics Corporation
• Investigators: Principal Investigator: Patrick Peeters, MD, Imelda Hospital, Bonheiden, Belgium; Principal Investigator: Marc Bosiers, MD, AZ St-Blasius, Dendermonde, Belgium

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: July 18, 2008
• First Submitted That Met QC Criteria: July 18, 2008
• First Posted (Estimate): July 21, 2008

Study Record Updates

• Last Update Posted (Estimate): March 9, 2015
• Last Update Submitted That Met QC Criteria: March 6, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: CLI; excimer laser; debulking
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: FMRP-005