Clinical trial NCT00718991: EXCimEr Laser for Long lENgTh Lesions in Below-The-Knee Arteries 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Peripheral Arterial Occlusive Disease
Keywords: CLI
excimer laser
debulking
Lead sponsor: Flanders Medical Research Program
Sponsor class: NETWORK
Collaborators: name: Spectranetics Corporation
First posted: 2008-07-21
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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
* 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

Primary outcomes:
measure: Angiographic patency for laser + PTA, as defined by < 50% stenosis in the target lesion with straight line flow to the foot
timeFrame: 12 months
measure: Absence of Major Adverse Events defined as death, amputation of treated limb and target vessel revascularization
timeFrame: 6 months
Secondary outcomes:
measure: 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
timeFrame: Procedure
measure: Absence of Major Adverse Events defined as death, amputation of treated limb and target vessel revascularization
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: 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
timeFrame: 12 months
measure: Health Economics assessment being: length of hospital stay, duration of the procedure, unplanned visits, retreatment and diagnostic procedure codes, material and medication costs
timeFrame: 12 months
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Hospital
city: Dendermonde
country: Belgium
facility: AZ St-Blasius
Study officials:
affiliation: Imelda Hospital, Bonheiden, Belgium
name: Patrick Peeters, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: AZ St-Blasius, Dendermonde, Belgium
name: Marc Bosiers, MD
role: PRINCIPAL_INVESTIGATOR
References: