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Peripheral Artery DiseasePhase 3CELLONCT00595959

CELLO - CLiRpath® Excimer Laser System to Enlarge Lumen Openings

A Phase 3 study testing CLiRpath Photoablation System in people with Peripheral Artery Disease, run by Spectranetics Corporation.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to evaluate the safety and efficacy of the CLiRpath® Photoablation Atherectomy System consisting of the Bias Sheath guiding catheter, in combination with the available CLiRpath® Excimer Laser Catheters ≤ 2.0 mm, to create larger lumens for treatment within the superficial femoral and… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Peripheral Artery Disease
What is being tested?
CLiRpath Photoablation System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
65 participants
Where
No sites listed yet
Study dates
Nov 2006to Apr 2008
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General Inclusion Criteria
  • Peripheral vascular disease Rutherford Classification 1, 2, or 3;
  • Eligible for revascularization of native vessel (PTA or bypass);
  • Willing and able to comply with the specified evaluations during hospitalization and all required follow-up examinations;
  • Written informed consent given before execution of study procedures; and
  • Age > 18 and ≤ 85 years.
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  • Angiographic Inclusion Criteria
  • Reference vessel diameter >/= 4.0 mm and ≤ 7.0 mm as determined by physician visual angiographic assessment of the most normally appearing vessel segment within 10 mm proximal AND 10 mm distal to the target segment.
  • Stenosis within the SFA and/or popliteal artery above the knee of >/= 70% and </= 100% DS (occlusion), as determined by visual angiographic assessment by the investigator at the time of the procedure and documented by angiography in at least two (2) orthogonal views.
  • At least 1.0 cm of visible SFA stump beyond the origin of the profunda artery.
  • Total lesion length >/= 1.0 cm and ≤ 15.0 cm as determined by visual angiographic assessment at the time of the procedure, separate multiple lesions can be combined as two separate treatment areas as long as the sum total of all lesion lengths and/or treatment areas does not exceed 1.0 cm to 15.0 cm.
  • Patency (< 50% DS) of at least one (1) infrapopliteal artery in continuity with the native femoropopliteal artery.
  • -

Who cannot join

  • General Exclusion Criteria
  • Contraindication to intravenous contrast material, heparin, aspirin or other medications required for a percutaneous interventional procedure;
  • Known bleeding or hyper-coagulation disorder;
  • Serum creatinine > 2.0 mg/dL;
  • Uncompensated congestive heart failure;
  • Current enrollment in any investigational study wherein patient participation has not been completed;
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  • Prior enrollment in this study;
  • Suspected or confirmed pregnancy;
  • Any patient, who in the opinion of the investigator, would not be a good candidate for enrollment;
  • Myocardial infarction within 60 days; and
  • CVA/TIA within 60 days. Angiographic Exclusion Criteria
  • 1.
  • Subintimal guidewire placement following pilot channel creation through a stenosis or occlusion with any excimer laser catheter, as visualized with IVUS;
  • Calcification likely to prevent the passage of the excimer laser catheter or CLiRpath® Photoablation Atherectomy system;
  • Ipsilateral and/or contralateral iliac stenosis >/= 50% DS that is not treated prior to enrollment in this study;
  • Ipsilateral and/or contralateral iliac treatment of a stenosis prior to enrollment with final residual stenosis >/= 30%, as determined in at least two (2) orthogonal views and documented by angiography;
  • Iliac treatment prior to enrollment where a perforation occurred requiring a covered stent, blood transfusion, or surgery for treatment of the perforation;
  • Identification of any lesion above the knee and/or below the knee in the treated leg (ipsilateral) that will require preplanned or predicted treatment within six (6) months after enrollment and prior to the completion of the six (6) month follow-up, including the iliac artery, the common femoral artery, the peroneal, anterior tibial, or posterior tibial arteries, or any area from the iliacs to the foot outside of the treatment area;
  • Lesions proximal and distal to the treatment site that are >/= 50% DS at time of enrollment;
  • Contralateral leg disease that requires treatment within the next 30 days and prior to completion of the 30 day follow-up;
  • Cardiovascular surgical or cardiovascular interventional procedures (including, but not limited to, aortic, renal, cardiac, carotid, femoro-popliteal, and below the knee) within 30 days prior to enrollment in this study;
  • Planned or predicted cardiovascular surgical or interventional procedures outside of the ipsilateral leg (including, but not limited to aortic, renal, cardiac, carotid, contralateral femoro-popliteal, and contralateral below the knee) within 30 days after entry into this study, and prior to completion of the 30-day follow-up; and
  • Perforation or dissection of grade "C" or greater seen during or after the creation of the pilot channel.

About this study

Official title: CLiRpath® Excimer Laser System to Enlarge Lumen Openings

The objective of this study is to evaluate the safety and efficacy of the CLiRpath® Photoablation Atherectomy System consisting of the Bias Sheath guiding catheter, in combination with the available CLiRpath® Excimer Laser Catheters ≤ 2.0 mm, to create larger lumens for treatment within the superficial femoral and popliteal arteries above the knee.

Being tested
CLiRpath Photoablation System
Medical subject headings
Peripheral Arterial Disease

What participants receive

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

  • CLiRpath Photoablation SystemDevice

    Use of CLiRpath Laser Catheter to improve vessel lumen diameter.

Study groups in NCT00595959
Study groupRoleWhat they receive
Laser TreatmentExperimentalCLiRpath Photoablation Atherectomy System
Receives: Device: CLiRpath Photoablation System

What is being measured

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

  1. Laser Success

    The primary efficacy endpoint is laser success, defined as achieving >/= 20% average reduction in the percent (%) diameter stenosis, post-laser and prior to adjunctive therapy, based on angiographic core laboratory assessment.

    Measured: Measured at time of procedure

  2. Major Adverse Events

    The primary safety endpoint is the occurrence of major adverse events defined as clinical perforation, major dissection requiring surgery, major amputation, cerebrovascular accidents (CVA), myocardial infarction, and death.

    Measured: From discharge through the 6 month follow-up

Secondary outcomes (9)

  1. Procedural Success

    Acute procedural success, defined as achievement of </= 30% final residual stenosis, as visually assessed by angiography after all adjunctive treatment(s) deemed necessary by the treating physician. Measures % of patients who achieved a final residual stenosis of </=30%.

    Measured: measured at time of procedure

  2. Minimum and Maximum Lumen Diameters

    Minimum and maximum lumen diameters immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by Intravascular Ultrasound (IVUS).

    Measured: measured at time of procedure

  3. Clinical Success

    Clinical success, defined as primary patency (≤ 50% stenosis at the treatment site), as assessed by duplex Doppler ultrasound at 30 days, six (6) months and 12 months post-procedure

    Measured: measured post discharge thorugh 12 Months follow-up

  4. Assisted Primary Patency

    Incidence of freedom from assisted primary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a stenosis (patent vessel) at the treatment site to prevent reocclusion

    Measured: Through 12 Months

  5. Assisted Secondary Patency

    Incidence of freedom from assisted secondary patency at 30 days, six (6) and 12 months post-procedure, defined as a re-intervention of a reocclusion (non-patent vessel) at the treatment site

    Measured: Through 12 Month

  6. Patients With >50% Stenosis Measured by Duplex Ultrasound

    Percentage of patients with >50% stenosis at each follow-up (30 days, six months, and 12 months post-procedure).

    Measured: Through 12 Month

  7. Rutherford Classification

    Rutherford Classification at 30 days, six (6) and 12 months post-procedure. Physician assessed based on ankle pressures and treadmill testing. Rutherford scale: 0=best, 6=worst

    Measured: Through 12 Months

  8. Adverse Events

    Adverse events during procedure and prior to release from the hospital, at 30 days, six (6) months, and 12 months post-procedure.

    Measured: Through 12 Months

  9. Volumetric Plaque Reduction

    Volumetric plaque reduction immediately after treatment with the CLiRpath® Photoablation Atherectomy System as determined by IVUS. Actual volume of plaque present is presented for each measurement point.

    Measured: measured at time of procedure

Timeline

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

  1. First posted16 Jan 2008 (estimated)
  2. Study startNov 2006
  3. Primary completionApr 2007
  4. Study completionApr 2008

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
65 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00595959
Sponsor's protocol ID
9000-0001-03 CELLO
Acronym
CELLO
Status last verified
Jun 2011
First submitted
4 Jan 2008
Last updated
12 Jul 2011
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CLiRpath Photoablation System in people with Peripheral Artery Disease, run by Spectranetics Corporation.

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 23 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: finished, as of the sponsor's last update on 12 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

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 phase mean?

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?

Yes. Results are posted in the registry (first posted 19 Jun 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Laser Success (time frame: Measured at time of procedure). 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 NCT00595959.

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 12 Jul 2011.

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