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Atherectomy in Diseased Lower Extremity ArteriesCOMBINENCT01775410

OptiCal COherence ToMography ABoard InformiNg AtherEctomy

A study testing Wolverine System to perform atherectomy in people with Atherectomy in Diseased Lower Extremity Arteries, run by Avinger, Inc. at 2 sites in Colombia.

Terminated

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

Official record
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Trial summary

This is a prospective, multi-center, non-randomized single arm feasibility trial of the Wolverine OCT guided atherectomy system.The trial will enroll up to 50 subjects diagnosed with peripheral vascular disease of the lower extremities.The primary disease must be located in reference vessel diameters ≥ 2.5 mm which is… Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Wolverine System to perform atherectomy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
2 sitesColombia
Study dates
Feb 2013to 27 Aug 2013
Phase
Interventional
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 100 years
  • 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 >2.5 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 Wolverine 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 Wolverine 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

2 sites in 1 country.

Colombia2 sites

  • Angiografia de Occidente

    Cali, VAC

  • Clinical Cardiovascular

    Medellín

Other trials in Colombia

About this study

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

This is a prospective, multi-center, non-randomized single arm feasibility trial of the Wolverine OCT guided atherectomy system.The trial will enroll up to 50 subjects diagnosed with peripheral vascular disease of the lower extremities.The primary disease must be located in reference vessel diameters ≥ 2.5 mm which is significant enough to cause moderate to severe symptoms and warrant vascular intervention.

Read the detailed description

This is a prospective, multi-center, non-randomized single arm feasibility trial of the Wolverine OCT guided atherectomy system. The trial is predominantly descriptive and, as such, not powered statistically although endpoint comparisons may be made to the published literature on peripheral atherectomy.

The trial will enroll up to 50 subjects diagnosed with peripheral vascular disease of the lower extremities. The primary disease must be located in reference vessel diameters ≥ 3.0 mm which is significant enough to cause moderate to severe symptoms and warrant vascular intervention. Trial success is focused on short term safety including rates of major adverse events. An evaluation of efficacy will also be performed and will include an evaluation of technical success defined as the percent of target lesions that has a residual diameter stenosis <50% post the Wolverine device alone as assessed by an independent review at the time of treatment using quantitative angiography or visual estimate.

Being tested
Wolverine System to perform atherectomy

What participants receive

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

  • Wolverine System to perform atherectomyDevice

Study groups in NCT01775410
Study groupRoleWhat they receive
Wolverine SystemExperimentalWolverine 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
Receives: Device: Wolverine System to perform atherectomy

What is being measured

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

  1. Number of Participants With no Major Adverse Events

    Freedom from major adverse events (MAE) through 30 day follow-up:

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

    Measured: Through 30 day follow-up

Secondary outcomes (5)

  1. Technical Success: Percent of Target Lesions That Have a Residual Diameter Stenosis < 50%

    Technical success is defined as the percent of target lesions that has a residual diameter stenosis < 50% post the Wolverine device alone as assessed by an independent review at the time of treatment using quantitative angiography or visual estimate

    Measured: During interventional procedure

  2. Procedural Success: Percent of Target Lesions That Have Residual Diameter Stenosis ≤30% Post-Wolverine and Any Other Adjunctive Therapy

    Measured: Day 0

  3. Number of Participants With no Procedural Emboli

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

    Measured: During interventional procedure

  4. Ankle-Brachial Index (ABI) at 30 Days

    Ankle-Brachial Index (ABI) is the ratio of blood pressure in the lower legs to the blood pressure in the arms. It is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressure in the arm.

    ABI < 0.95 indicates arterial disease; ABI between 0.95 and 1.3 is considered normal (free from significant peripheral artery disease); ABI > 1.3 is abnormal, and suggests calcification of the artery walls and incompressible vessels, indicating severe peripheral vascular disease.

    Measured: At 30 days

  5. Rutherford Classification at 30 Days Post-procedure

    Rutherford Classification is a commonly used clinical means for describing the degree of peripheral artery disease. Rutherford Classifications range from Class 0: Asymptomatic, to Class 6: Major Tissue Loss. A lower score is less severe disease and a higher score is more severe disease progression.

    Measured: At 30 days

Timeline

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

  1. First posted25 Jan 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionAug 2013
  4. Study completion27 Aug 2013

Why it stopped: Study was terminated by sponsor without any AEs to review the device design.

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
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01775410
Sponsor's protocol ID
P 0218
Acronym
COMBINE
Status last verified
Apr 2021
First submitted
14 Jan 2013
Last updated
21 Apr 2021
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Wolverine System to perform atherectomy in people with Atherectomy in Diseased Lower Extremity Arteries, run by Avinger, Inc. at 2 sites in Colombia.

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: stopped early, as of the sponsor's last update on 21 Apr 2021. 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 Colombia. 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?

Yes. Results are posted in the registry (first posted 21 Apr 2021). 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?

Number of Participants With no Major Adverse Events (time frame: Through 30 day follow-up). 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 NCT01775410.

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 21 Apr 2021.

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