Axys ACHIEVE: Pivotal Study of the Medtronic Axys EX Rotational Atherectomy System

Sponsor

Medtronic Endovascular (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT04282161

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The primary objective is to demonstrate the safety and effectiveness of the Axys EX rotational atherectomy system in subjects with peripheral arterial disease who have de novo or non-stented restenotic obstructive lesions in the peripheral vasculature of the lower limbs.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease	Device: Axys EX device	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pivotal Study of the Medtronic Axys EX Rotational Atherectomy System for the Treatment of Peripheral Arterial Disease in the Vasculature of the Lower Limbs

Anticipated Study Start Date :

Dec 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Axys EX device	Device: Axys EX device Rotational atherectomy system for endovascular treatment of peripheral arterial disease prior to adjunctive therapy, if needed Other Names: Axys EX

Arm

Intervention/Treatment

Experimental: Axys EX device

Device: Axys EX device

Rotational atherectomy system for endovascular treatment of peripheral arterial disease prior to adjunctive therapy, if needed

Other Names:

Axys EX

Outcome Measures

Primary Outcome Measures

Primary Effectiveness [During procedure]
Change in percent stenosis in the treatment vessel. Percent stenosis is defined as native vessel diameter as measured at the narrowest point of the lesion divided by the estimated native vessel diameter at that location.
Primary Safety [30-Days]
Major Adverse Events (MAEs) at 30 Days post-procedure defined as freedom from clinically-driven target lesion revascularization (CD-TLR), major unplanned amputation of the treated limb, or all-cause mortality.

Secondary Outcome Measures

Technical Success [During Procedure]
Defined as the ability of the Axys EX device to successfully traverse/cross the entire intended length of the target lesion
Procedural Success [During Procedure]
Defined as ≤ 30% residual stenosis following use of the Axys EX device and adjunctive therapy as measured by angiography and determined by the angiographic core laboratory
Amputation-Free Survival [12-Months]
Defined as freedom from a major, unplanned amputation of the target limb through the 12 month visit
Major Adverse Events (MAEs) [12-Months]
Defined as freedom from clinically-driven target vessel revascularization (CD-TVR), major unplanned amputation of the treated limb, thrombosis at the target lesion site, or all-cause mortality
Rate of Target Lesion Revascularization (TLR) [6 and 12-Months]
Any re-intervention at the target lesion
Rate of Target Vessel Revascularization (TVR) [6 and 12-Months]
Any re-intervention within the target vessel
Provisional Stent Rate [During Procedure]
Flow Limiting Dissection [During Procedure]
Target lesion flow limiting dissection (D or greater) rate after adjunctive therapy
Primary Patency as determined by Duplex Ultrasound (DUS) [6 and 12-Months]
For subjects with a target lesion in the femoropopliteal region (above the knee [ATK]) through the level of popliteal segment P3 (below the knee popliteal artery from the center of the knee joint space to the origin of anterior tibial artery), primary patency is defined as freedom from core laboratory-assessed restenosis (DUS PSVR ≤2.4) and CD-TLR (adjudicated by a Clinical Events Committee) For subjects with a target lesion below the level of popliteal segment P3 (below the knee [BTK]), primary patency is defined as freedom from core laboratory-assessed absence of target lesion occlusion (no flow) as assessed by DUS and CD-TLR (adjudicated by a Clinical Events Committee)
Quality of Life Assessment [30-Days, 6 and 12-Months]
EQ-5D questionnaire
Walking Distance [30-Days, 6 and 12-Months]
6-Minute Walking Test
Walking Capacity [30-Days, 6 and 12-Months]
Walking Impairment Questionnaire (WIQ)
Ankle/brachial index (ABI) or toe/brachial index (TBI) [30-Days, 6 and 12-Months]
Rutherford clinical category (RCC) [30-Days, 6 and 12-Months]
Distal Embolization in Target Limb [30-Days]
Clinically significant distal embolization in target limb within 30 days defined as distal embolization requiring treatment by mechanical or pharmacologic means (other than a vasodilator) (adjudicated by a Clinical Events Committee)
Major Vessel Perforation [30-Days]
requiring surgical or endovascular repair within 30 days (adjudicated by a Clinical Events Committee) 6.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

General Inclusion Criteria:

Rutherford Clinical Category (RCC) Score of 2 - 5
Willing and capable of complying with all follow-up evaluations at the specified times
Age ≥ 18 years old
Provides written informed consent prior to study specific procedures
Completed Ankle/Brachial Index (ABI) (or Toe/Brachial Index [TBI]) prior to index procedure (up to 60 days prior)

Angiographic Inclusion Criteria:

Evidence of ≥ 70% stenosis or occlusion in the peripheral vasculature of the target vessel, confirmed by angiography
Target lesion present in a single limb that consists of a single de novo or non-stented restenotic lesion, or qualifies as a tandem or combination lesion per the definitions below:
Tandem (adjacent) Lesion: Lesions present in the same target vessel that can be treated as one single lesion and is separated by an angiographic normal vessel ≤3 cm at any point. Multiple points of separation can be present in single lesion treatment if no single point of separation is > 3 cm
Combination Lesion: A single lesion that is not completely occluded but includes a segment of complete occlusion anywhere along the length
Exchangeable guidewire must cross target lesion within the lumen
Total target lesion length is ≥ 20 mm and ≤ 200mm
Reference vessel diameter (RVD) is ≥ 2.0 mm and ≤ 5.0 mm
Identifiable distal target vessel which upon completion of the intervention is anticipated to provide reconstitution of blood flow to the foot. Angiographic evidence of adequate distal runoff through the foot (at least one native calf vessel [posterior tibial, anterior tibial, or peroneal artery] is patent, defined as < 50% stenosed)
Multiple lesions in the target limb (including the target lesion and non-target lesions) may be treated if all of the following applies:
Non-target lesion(s) must be located proximal to the target lesion
Non-target lesion(s) must be successfully treated (defined as optimally treated [e.g. no untreated arterial dissections or perforation present]) by standard endovascular procedures prior to initiation of treatment of the target lesion
Non-target lesions treated prior to target lesion cannot be treated with rotational, orbital or laser atherectomy
Non-target lesion(s) may be located in separate vascular beds (i.e., iliac,femoropopliteal, tibial) or multiple tibial vascular beds (i.e., anterior tibial, posterior tibial, tibioperoneal trunk/peroneal). (Note: Only one tibial vessel may be identified as the target vessel with the target lesion.)
Only one lesion per the above definitions may be treated as the target lesion with the Axys EX device

General Exclusion Criteria:

Has one or more of the contraindications listed in the Axys EX Rotational Atherectomy System's IFU
Contraindication or known untreated allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs, or any other drug anticipated to be used
Hypersensitivity to contrast material that cannot be adequately pretreated
Known uncontrollable hypercoagulable condition or refuses blood transfusion
Life expectancy of less than 12 months
Surgical (requiring hospitalization) or endovascular intervention of the target limb within 30 days prior to the index procedure
Planned surgical intervention or endovascular procedure within 30 days after the index procedure
Currently participating in an investigational drug or another device study that may clinically interfere with the study endpoints
Other co-morbid condition(s) that in the judgment of the physician precludes safe percutaneous intervention
If a previous peripheral bypass affecting the target limb is present, the bypass must be patent and the target lesion cannot be present in the peripheral bypass artery
Impaired renal function (defined as GFR < 30 mL/min) or on dialysis
Recent myocardial infarction or stroke ≤ 30 days prior to the index procedure
Previous or planned amputation above the metatarsal line on the target limb
Patient belongs to a vulnerable population per investigator's judgment or patient has any kind of disorder that compromises his/her ability to give written informed consent and/or to comply with study procedures. Patient must be able to consent for themselves
Patient is pregnant (female patients of child-bearing potential must have a pregnancy test done within 7 days prior to the index procedure)

Angiographic Exclusion Criteria:

Noted thrombus at the point of the intended target lesion
In-stent restenosis of the target lesion
Aneurysmal target vessel
Hemodynamic significant stenosis or occlusion of inflow tract that has not been revascularized prior to treatment of the target vessel
Perforation, flow limiting dissection or other injury of the target vessel requiring surgical intervention prior to enrollment
Disease that precludes safe advancement of the Axys EX device to the target lesion
Need to treat a lesion distal to the target index lesion

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Medtronic Endovascular

Investigators

Principal Investigator: Ravish Sachar, MD FACC, North Carolina Heart and Vascular
Principal Investigator: Brian DeRubertis, MD FACS, University of California, Los Angeles