EXCimEr Laser for Long lENgTh Lesions in Below-The-Knee Arteries Study

NCT ID: NCT00718991

Last Updated: 2015-03-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2009-07-31

Brief Summary

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.

Conditions

Peripheral Arterial Occlusive Disease

Study Design

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

Study Groups

1

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

Group Type: EXPERIMENTAL

Spectranetics Turbo elite™ excimer laser catheter

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

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

Sponsors

Spectranetics Corporation

INDUSTRY

Sponsor Role: collaborator

Flanders Medical Research Program

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Peeters, MD

Role: PRINCIPAL_INVESTIGATOR

Imelda Hospital, Bonheiden, Belgium

Marc Bosiers, MD

Role: PRINCIPAL_INVESTIGATOR

AZ St-Blasius, Dendermonde, Belgium

Locations

Imelda Hospital

Bonheiden, , Belgium

AZ St-Blasius

Dendermonde, , Belgium

Countries

Belgium

Other Identifiers

FMRP-005

Identifier Type: -

Identifier Source: org_study_id