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Post-Market Registry of AURYON™ Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease (PATHFINDER-I)

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ClinicalTrials.gov Identifier: NCT04229563
Recruitment Status : Not yet recruiting
First Posted : January 18, 2020
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Angiodynamics, Inc.

Brief Summary:
The PATHFINDER I Registry is a prospective, non-randomized, single arm, multicenter observational study. It is a pilot registry study towards a subsequent large pivotal phase registry. This pilot registry is aimed to evaluate the performance (peri-procedural) and clinical outcomes (intermediate and long-term) of the AURYON™ Atherectomy System, within the initial launch phase of the product in the market.

Condition or disease Intervention/treatment
Infrainguinal Peripheral Artery Disease Peripheral Arterial Disease PAD Device: AURYON™ System

Detailed Description:
US multicenter, prospective, single-arm, observational post market Registry. A pilot registry towards a subsequent large pivotal registry (PATHFINDER II), aimed to evaluate the safety and efficacy of Auryon™ Atherectomy System in the treatment of de novo, re-stenotic and ISR lesions in infra-inguinal arteries of Peripheral Artery Diseases (PAD) subjects, in a real-world setting within the initial launch phase of the product in the market.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: PATHFINDER I: Post-Market Registry of AURYON™ Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease (PATHFINDER-Registry, EX-PAD-05)
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Study patients
Eligible PAD patients who are routinely treated with atherectomy by AURYON™ Atherectomy System.
Device: AURYON™ System
The AURYON™ System consists of two sub-units: 1) a single use catheter ("AURYON™ catheter"); and 2) a laser system.




Primary Outcome Measures :
  1. Primary Efficacy: Acute Procedural Success [ Time Frame: Peri-procedural (by the end of the index procedure) ]
    Percentage of subjects with successful revascularization of target vessel defined as ≤30% residual stenosis at the index lesion post AURYON™ atherectomy and final adjunctive treatment (if required), as evaluated by angiographic corelab.

  2. Primary Safety: Freedom from Peri-procedural major adverse events (PPMAE) [ Time Frame: Till discharge, an average of 5 days ]
    Percentage of subjects with freedom from peri-procedural major adverse events (PPMAE), defined as (a) flow-limiting dissection, (b) clinically significant distal embolization, (c) bailout stenting, (d) major/unplanned amputation, (e) target vessel perforation requiring endovascular or surgical repair or (f) death, till discharge.


Secondary Outcome Measures :
  1. Rate of device related complications requiring intervention [ Time Frame: Till discharge, an average of 5 days ]
    Rate of device related complications requiring intervention, defined as peri procedural MAEs, reported by the operating physician as caused directly due to the use of the AURYON device.

  2. Rates of MAEs over time [ Time Frame: Post-discharge (at 30-days, 6-, 12-, and 24-months) ]
    Rates of post-discharge MAEs over time; defined as: (a) Unplanned target limb amputation, (b) cardiovascular death, (c) clinically driven target lesion revascularization , (d) target vessel revascularization (TVR).

  3. Patency rate [ Time Frame: Post-discharge (at 6-, 12-, and 24-months) ]
    Patency rate, defined as <50% stenosis at the treated lesion, with peak systolic velocity ratio (PSVR) of <2.5, as assessed quantitatively by Duplex ultrasonography (DUS) performed in a lab that achieved Vascular Laboratory Accreditation, at 6, 12, and 24 months.

  4. Occlusion freedom [ Time Frame: Post-discharge (at 6-, 12-, and 24-months) ]
    Only for BTK lesions: freedom from occlusion (100% stenosis by DUS) combined with freedom from CD-TLR

  5. Clinical outcome 1 - ankle brachial index (ABI) [ Time Frame: Post-discharge (at 6-, 12-, and 24-months) ]

    Change in ankle brachial index (ABI or TBI if needed) at 6, 12, and 24, months, compared to baseline.

    Ankle-Brachial Index (ABI) si an ankle/arm blood pressure ratio. Normal value ranges between 0.9-1.3. Under 0.9 index means blood has a difficult time getting to legs & feet; 0.4-0.9 indicates mild-moderate PAD; 0.4 and lower indicates severe PAD. Positive difference between time-points represents a clinical improvement through time and vice versa.


  6. Clinical outcome 2 - walking impairment questionnaire (WIQ) [ Time Frame: Post-discharge (at 6-, 12-, and 24-months) ]

    Change in walking impairment questionnaire (WIQ) score at 6, 12, and 24, months, compared to baseline.

    WIQ is a patient fulfilled survey to grade physical ability representing PAD progress, has 3 sub-scales (walking speed, distance, climbing stairs), when the total score ranges between 0-100, higher value = better outcome. Positive difference between time-points represents a clinical improvement through time and vice versa.


  7. Clinical outcome 3 - Rutherford clinical categories (RCC) [ Time Frame: Post-discharge (at 6-, 12-, and 24-months) ]

    Change in Rutherford clinical category at 6, 12, and 24, months, compared to baseline.

    Rutherford Classification is a doctor determined 7 stages scale (0= Asymptomatic, 6= Severe ischemic ulcers/frank gangrene) representing PAD progress, lower value = better outcome. Positive difference between time-points represents a clinical deterioration through time and vice versa.



Other Outcome Measures:
  1. Exploratory endpoint: IVUS [ Time Frame: Peri-procedural (by the end of the index procedure) ]
    Intravascular ultrasound assessment pre- and post-Auryon and correlation with angiographic findings (e.g. lesion length, MLA -minimal lumen area gain, calcium severity and removal, etc.). This endpoint will be analyzed only for cases that used IVUS as a routine practice in the index procedure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with infra-inguinal PAD undergoing atherectomy with the AURYON™ Atherectomy System.
Criteria

Inclusion Criteria:

  1. Subject is ≥ 18 years old.
  2. Subject is a candidate for atherectomy for infra-inguinal peripheral artery disease.
  3. Documented symptomatic atherosclerotic peripheral artery disease with claudication or critical limb ischemia (CLI) (Rutherford Classification 2-5 ).
  4. Subject is capable and willing to comply with the scheduled follow up
  5. Subject is able and willing to sign a written Informed Consent Form (ICF).

Exclusion Criteria:

  1. Target lesion is in an arterial bypass.
  2. Planned use of another atherectomy device in the same procedure
  3. Co-morbid condition(s) with less than 1yr anticipated survival that could limit the subject's ability to participate in the trial or to comply with follow-up requirements or impact the scientific integrity of the study.
  4. Participating in another study on an interventional non-cleared device, that could impact the study results

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04229563


Contacts
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Contact: Alicia Conway 7742498707 aconway@angiodynamics.com

Sponsors and Collaborators
Angiodynamics, Inc.
Investigators
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Study Chair: TBD TBD
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Responsible Party: Angiodynamics, Inc.
ClinicalTrials.gov Identifier: NCT04229563    
Other Study ID Numbers: EX-PAD-05
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Angiodynamics, Inc.:
Peripheral Artery Disease
Peripheral Occlusive Disease
Peripheral Artery Stenonsis
Artery Restenosis
Arterial Occlusive Disease
Peripheral Vascular disease
Laser recanalization
Endovascular treatment or Procedure or Surgery
Calcified Lesions
Atherectomy
Intermittent Claudication
Claudication pain
Arterial Calcification
Critical Limb Ischemia
CLI
Acute Limb Ischemia
Acute Arterial Occlusion
Infra-inguinal Stenosis or Occlusion
Femoral Artery Stenosis
Femoral-Popliteal Arterial Disease
Tibial Stenosis
In-stent Restenosis
Stenotic lesion
Peripheral Artery Revascularization
Lower Limb Arterial Calcification
Laser-assisted angioplasty
Above the Knee calcification
ATK Calcification
Below the Knee Calcification
Chronic total occlusion
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases