Pivotal Study of the Medtronic Axys EX Rotational Atherectomy System

NCT04282161 | Withdrawn DMC FDA Device

• 1 other identifier: MDT17045
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Vascular Disease; Critical Limb Ischemia; Superficial Femoral Artery Stenosis; Atherosclerosis; Arteriosclerosis; Vascular Diseases; Arterial Disease Occlusive; lower extremity arterial disease

Outcome Measures

Primary Outcomes (2)

• Primary Effectiveness

  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.

  During procedure

• Primary Safety

  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.

  30-Days

Secondary Outcomes (16)

• Technical Success

  During Procedure

• Procedural Success

  During Procedure

• Amputation-Free Survival

  12-Months

• Major Adverse Events (MAEs)

  12-Months

• Rate of Target Lesion Revascularization (TLR)

  6 and 12-Months

Study Arms (1)

Axys EX device

EXPERIMENTAL

Device: Axys EX device

Interventions

Axys EX device DEVICE

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

Also known as: Axys EX

Axys EX device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medtronic Endovascular: lead

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases; Chronic Limb-Threatening Ischemia; Atherosclerosis; Arteriosclerosis; Vascular Diseases; Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Ravish Sachar, MD FACC

  North Carolina Heart and Vascular

  PRINCIPAL INVESTIGATOR

• Brian DeRubertis, MD FACS

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 24, 2020
• Study Start: December 1, 2021
• Primary Completion: August 1, 2023
• Study Completion: February 1, 2024
• Last Updated: April 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share