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

Flanders Medical Research Program

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Peripheral Arterial Occlusive Disease

Treatments: Device: Spectranetics Turbo elite™ excimer laser catheter

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT00718991

FMRP-005

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

1

Experimental group

Description:

CLI patients receiving excimer laser recanalisation for the treatment of long infrapopliteal lesions

Treatment:

Device: Spectranetics Turbo elite™ excimer laser catheter