WithdrawnNot Applicable

Pivotal Study of the Medtronic Axys EX Rotational Atherectomy System

Stopped: Business Decision

0Started 2021-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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)
✓. 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

Exclusion criteria

✕3. Has one or more of the contraindications listed in the Axys EX Rotational Atherectomy System's IFU
✕4. Contraindication or known untreated allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs, or any other drug anticipated to be used
✕5. Hypersensitivity to contrast material that cannot be adequately pretreated
✕6. Known uncontrollable hypercoagulable condition or refuses blood transfusion
✕7. Life expectancy of less than 12 months
✕8. Surgical (requiring hospitalization) or endovascular intervention of the target limb within 30 days prior to the index procedure
✕9. Planned surgical intervention or endovascular procedure within 30 days after the index procedure
✕0. Currently participating in an investigational drug or another device study that may clinically interfere with the study endpoints

What they're measuring

Primary Effectiveness

Timeframe: During procedure

Primary Safety

Timeframe: 30-Days

Trial details

NCT IDNCT04282161

SponsorMedtronic Endovascular

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08

View on ClinicalTrials.gov More Peripheral Arterial Disease trials