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Peripheral Arterial DiseaseCOMBINE-IINCT02126540

Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries

A study testing Pantheris Atherectomy System in people with Peripheral Arterial Disease, run by Avinger, Inc. at 1 site in New Zealand.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

To evaluate the safety and effectiveness of the Pantheris System to perform atherectomy while using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Arterial Disease
What is being tested?
Pantheris Atherectomy System
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteNew Zealand
Study dates
Sep 2015to Jul 2016
Phase
Interventional
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

  • Age ≥ 18 years old.
  • Patient is a candidate for percutaneous intervention for peripheral vascular disease in the legs.
  • Patient is willing and able to give informed consent
  • Documented symptomatic atherosclerotic peripheral vascular disease Rutherford Classification 2-5.
  • Reference vessel lumen proximal to target lesion >3.0 mm in diameter by visual estimation.
  • Subject has de novo target lesion(s) with stenosis >70% by visual estimation distal to the profunda femoral artery. No more than 2 lesions may be treated with the Pantheris device.
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  • Target lesion length <10 cm if target lesion >70% and <99% stenosed. If target lesion a chronic total occlusion (99-100% stenosed), target lesion length <4 cm.
  • Patient is capable of meeting requirements and be present at the follow-up clinic visits at 30 days.
  • At least one patent tibial run-off vessel at baseline. -

Who cannot join

  • Subject is pregnant or breast feeding.
  • Rutherford Class 0 to 1 (asymptomatic and mild claudication).
  • Rutherford Class 6 (critical limb ischemia).
  • Severe calcification of the target lesion.
  • Target lesion with any type of stent or graft.
  • Target lesion in the iliac artery.
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  • Target lesion stenosis <70%.
  • Subjects with significant (>70%) occlusive lesions proximal to the target lesion not successfully treated during the index procedure (upstream disease) and prior to treatment of the target lesion.
  • Endovascular or surgical procedure performed on the index limb less than or equal to 30 days prior to the index procedure.
  • Planned endovascular or surgical procedure 30 days after the index procedure.
  • Lesion in the contralateral limb requiring intervention during the index procedure or within 30 days of the index procedure.
  • Subjects with active infections whether they are being currently treated or not.
  • Hemodialysis or GFR <30 mL/min or creatinine level >2.5mg/dL.
  • Evidence or history of intracranial or gastrointestinal bleeding, intracranial aneurysm, myocardial infarction or stroke within the past 2 months.
  • Evidence or history of aneurysmal target vessel within the past 2 months.
  • History of severe trauma, fracture, major surgery or biopsy of a parenchymal organ within the past 14 days.
  • Known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
  • Subjects in whom anti-platelet, anticoagulant, or thrombolytic therapy is contraindicated.
  • History of heparin-induced thrombocytopenia (HIT).
  • Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 125,000/mm2 , known coagulopathy, or INR >1.5.
  • Any thrombolytic therapy within 2 weeks of the index procedure.
  • Any clinical and/or angiographic complication attributed to the use of another device prior to the insertion of the Pantheris into the subject.
  • Subjects or their legal guardians who have not or will not sign the Informed Consent.
  • Subjects who are unwilling or unable to comply with the follow-up study requirements.
  • Participation in any study of an investigational device, medication, biologic or other agent within 30 days prior to enrollment that is either a cardiovascular study or could, in the judgment of the investigator, affect the results of the study.

Trial locations and contacts

1 site in 1 country.

New Zealand1 site

  • Auckland City Hospital

    Auckland, 1023

Other trials in New Zealand

About this study

Official title: A Non-randomized, Multi-center Feasibility Trial of the Avinger Pantheris System, an Atherectomy Device That Provides Directional Visualization and Imaging While Removing Plaque in Diseased Lower Extremity Arteries

To evaluate the safety and effectiveness of the Pantheris System to perform atherectomy while using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries.

Being tested
Pantheris Atherectomy System
Keywords
Peripheral Arterial Disease, Atherectomy, Optical Coherence Tomography
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.

  • Pantheris Atherectomy SystemDevice

    Also called Pantheris

    Treatment device in primary cohort arm; OCT image guided directional atherectomy

Study groups in NCT02126540
Study groupRoleWhat they receive
Primary CohortExperimentalMain cohort; treatment Arm with Pantheris Atherectomy System
Receives: Device: Pantheris Atherectomy System

What is being measured

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

  1. Primary Safety Endpoint

    The primary safety endpoint is defined as freedom from major adverse events (MAE) through 30 day follow-up:

    • Clinically driven target lesion revascularization (TLR)
    • Myocardial infarction (MI)
    • Cardiovascular related deaths
    • Unplanned, major index limb amputation
    • Device Related Events:
    • Clinically Significant Perforations
    • Clinically Significant Dissections
    • Clinically Significant Embolus
    • Pseudoaneurysm

    Measured: Day 0 through Day 30

  2. Primary Effectiveness Endpoint

    The primary efficacy endpoint of technical success is defined as the percent of target lesions that has a residual diameter stenosis <50% post the Pantheris device alone as assessed by an independent review at the time of treatment using quantitative angiography or visual estimate.

    Measured: Day 0

Secondary outcomes (4)

  1. Secondary Safety Endpoint

    Freedom from procedural emboli, defined as a new occlusion of any visualized runoff vessel which cannot be reversed with an intravascular vasodilator.

    Measured: Day 0

  2. Secondary Effectiveness Endpoint

    Procedural success defined as the percent of target lesions that have residual diameter stenosis < 30% post-Pantheris and any other adjunctive therapy.

    Measured: Day 0

  3. Secondary Effectiveness Endpoint

    Ankle-Brachial Index at 30 days

    Measured: Day 30

  4. Secondary Effectiveness Endpoint

    Rutherford Classification at 30 days.

    Measured: Day 30

Timeline

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

  1. First posted30 Apr 2014 (estimated)
  2. Study startSep 2015
  3. Primary completionJan 2016 (estimated)
  4. Study completionJul 2016 (estimated)

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02126540
Sponsor's protocol ID
P0638
Acronym
COMBINE-II
Status last verified
Dec 2015
First submitted
28 Apr 2014
Last updated
16 Dec 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Pantheris Atherectomy System in people with Peripheral Arterial Disease, run by Avinger, Inc. at 1 site in New Zealand.

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 9 inclusion and 25 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: withdrawn, as of the sponsor's last update on 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in New Zealand. 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.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Primary Safety Endpoint (time frame: Day 0 through Day 30). 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 NCT02126540.

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 16 Dec 2015.

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