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

Primary Purpose

Peripheral Arterial Occlusive Disease

Status
Terminated
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Spectranetics Turbo elite™ excimer laser catheter
Sponsored by
Flanders Medical Research Program
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Occlusive Disease focused on measuring CLI, excimer laser, debulking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Imelda Hospital
  • AZ St-Blasius

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

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

Outcomes

Primary Outcome Measures

Angiographic patency for laser + PTA, as defined by < 50% stenosis in the target lesion with straight line flow to the foot
Absence of Major Adverse Events defined as death, amputation of treated limb and target vessel revascularization

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
Absence of Major Adverse Events defined as death, amputation of treated limb and target vessel revascularization
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
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
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
Health Economics assessment being: length of hospital stay, duration of the procedure, unplanned visits, retreatment and diagnostic procedure codes, material and medication costs

Full Information

First Posted
July 18, 2008
Last Updated
March 6, 2015
Sponsor
Flanders Medical Research Program
Collaborators
Spectranetics Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00718991
Brief Title
EXCimEr Laser for Long lENgTh Lesions in Below-The-Knee Arteries Study
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
too slow enrollment
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Flanders Medical Research Program
Collaborators
Spectranetics Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Occlusive Disease
Keywords
CLI, excimer laser, debulking

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
CLI patients receiving excimer laser recanalisation for the treatment of long infrapopliteal lesions
Intervention Type
Device
Intervention Name(s)
Spectranetics Turbo elite™ excimer laser catheter
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Title
Absence of Major Adverse Events defined as death, amputation of treated limb and target vessel revascularization
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
Title
Absence of Major Adverse Events defined as death, amputation of treated limb and target vessel revascularization
Time Frame
12 months
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Peeters, MD
Organizational Affiliation
Imelda Hospital, Bonheiden, Belgium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marc Bosiers, MD
Organizational Affiliation
AZ St-Blasius, Dendermonde, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imelda Hospital
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
AZ St-Blasius
City
Dendermonde
ZIP/Postal Code
9200
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.fmrp.be
Description
Related Info

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

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