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Peripheral Arterial Occlusive DiseasePhase 2/3EXCELLENT-BTKNCT00718991

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

A Phase 2/3 study testing Spectranetics Turbo elite™ excimer laser catheter in people with Peripheral Arterial Occlusive Disease, run by Flanders Medical Research Program at 2 sites in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Arterial Occlusive Disease
What is being tested?
Spectranetics Turbo elite™ excimer laser catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
2 sitesBelgium
Study dates
Jul 2008to Jul 2009
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites

  • Imelda Hospital

    Bonheiden, 2820

  • AZ St-Blasius

    Dendermonde, 9200

Other trials in Belgium

About this 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

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.

Being tested
Spectranetics Turbo elite™ excimer laser catheter
Keywords
CLI, excimer laser, debulking
Medical subject headings
Peripheral Arterial Occlusive Disease 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spectranetics Turbo elite™ excimer laser catheterDevice

    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.

Study groups in NCT00718991
Study groupRoleWhat they receive
1ExperimentalCLI patients receiving excimer laser recanalisation for the treatment of long infrapopliteal lesions
Receives: Device: Spectranetics Turbo elite™ excimer laser catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Angiographic patency for laser + PTA, as defined by < 50% stenosis in the target lesion with straight line flow to the foot

    Measured: 12 months

  2. Absence of Major Adverse Events defined as death, amputation of treated limb and target vessel revascularization

    Measured: 6 months

Secondary outcomes (6)

  1. 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

    Measured: Procedure

  2. Absence of Major Adverse Events defined as death, amputation of treated limb and target vessel revascularization

    Measured: 12 months

  3. 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

    Measured: 12 months

  4. 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

    Measured: 12 months

  5. 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

    Measured: 12 months

  6. Health Economics assessment being: length of hospital stay, duration of the procedure, unplanned visits, retreatment and diagnostic procedure codes, material and medication costs

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jul 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionJul 2009
  4. Study completionJul 2009

Why it stopped: too slow enrollment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00718991
Sponsor's protocol ID
FMRP-005
Acronym
EXCELLENT-BTK
Status last verified
Mar 2015
First submitted
18 Jul 2008
Last updated
9 Mar 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Spectranetics Turbo elite™ excimer laser catheter in people with Peripheral Arterial Occlusive Disease, run by Flanders Medical Research Program at 2 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: too slow enrollment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00718991.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2015.

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