Post-Market Registry of AURYON™ Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease (PATHFINDER-I)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04229563|
Recruitment Status : Active, not recruiting
First Posted : January 18, 2020
Last Update Posted : April 8, 2021
|Condition or disease||Intervention/treatment|
|Infrainguinal Peripheral Artery Disease Peripheral Arterial Disease PAD||Device: AURYON™ System|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||104 participants|
|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)|
|Actual Study Start Date :||August 4, 2020|
|Actual Primary Completion Date :||March 17, 2021|
|Estimated Study Completion Date :||March 31, 2023|
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 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.
- 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.
- 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.
- 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).
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
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
|United States, Arizona|
|Scottsdale, Arizona, United States, 85259|
|Tucson, Arizona, United States, 85718|
|United States, Florida|
|Davenport, Florida, United States, 33837|
|United States, Iowa|
|Midwest Cardio. research foundation|
|Davenport, Iowa, United States, 52803|
|United States, Texas|
|New Braunfels, Texas, United States, 78130|
|Study Chair:||TBD TBD|