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

Peripheral Arterial Occlusive Disease Clinical Trial

— EXCELLENT-BTK  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00718991
• Other study ID #: FMRP-005
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: July 18, 2008
• Last updated: March 6, 2015
• Start date: July 2008
• Est. completion date: July 2009

Study information

• Verified date: March 2015
• Source: Flanders Medical Research Program
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Disease
• Peripheral Arterial Occlusive Disease

Intervention

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.

Locations

Country	Name	City	State
Belgium	Imelda Hospital	Bonheiden
Belgium	AZ St-Blasius	Dendermonde

Sponsors (2)

Lead Sponsor	Collaborator
Flanders Medical Research Program	Spectranetics Corporation

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic patency for laser + PTA, as defined by < 50% stenosis in the target lesion with straight line flow to the foot		12 months	No
Primary	Absence of Major Adverse Events defined as death, amputation of treated limb and target vessel revascularization		6 months	Yes
Secondary	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	No
Secondary	Absence of Major Adverse Events defined as death, amputation of treated limb and target vessel revascularization		12 months	Yes
Secondary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No

External Links

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