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

Sponsors and Collaborators:	Flanders Medical Research Program Spectranetics Corporation
Information provided by:	Flanders Medical Research Program
ClinicalTrials.gov Identifier:	NCT00718991

Purpose

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.

Condition	Intervention	Phase
Peripheral Arterial Occlusive Disease	Device: Spectranetics Turbo elite™ excimer laser catheter	Phase II Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Flanders Medical Research Program:

Primary Outcome Measures:

Angiographic patency for laser + PTA, as defined by < 50% stenosis in the target lesion with straight line flow to the foot [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Absence of Major Adverse Events defined as death, amputation of treated limb and target vessel revascularization [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 [ Time Frame: Procedure ] [ Designated as safety issue: No ]
Absence of Major Adverse Events defined as death, amputation of treated limb and target vessel revascularization [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Health Economics assessment being: length of hospital stay, duration of the procedure, unplanned visits, retreatment and diagnostic procedure codes, material and medication costs [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.

Arms

Assigned Interventions

1: Experimental

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718991

Contacts

Contact: Patrick Peeters, MD	+3215506197	patrick.peeters@imelda.be
Contact: Koen De Meester	+3252252822	koen.demeester@fmrp.be

Locations

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

Sponsors and Collaborators

Flanders Medical Research Program

Spectranetics Corporation

Investigators

Principal Investigator:	Patrick Peeters, MD	Imelda Hospital, Bonheiden, Belgium
Principal Investigator:	Marc Bosiers, MD	AZ St-Blasius, Dendermonde, Belgium

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Flanders Medical Research Program ( Flanders Medical Research Program )
Study ID Numbers:	FMRP-005
Study First Received:	July 18, 2008
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00718991
Health Authority:	Belgium: Institutional Review Board

Keywords provided by Flanders Medical Research Program:

CLI
excimer laser
debulking

Study placed in the following topic categories:

Arterial Occlusive Diseases
Vascular Diseases
Ischemia

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 13, 2009