Status:
WITHDRAWN
Pivotal Study of the Medtronic Axys EX Rotational Atherectomy System
Lead Sponsor:
Medtronic Endovascular
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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 restenoti...
Eligibility Criteria
Inclusion
- General
- 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
- 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
- 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
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04282161
Start Date
December 1 2021
End Date
February 1 2024
Last Update
April 5 2021
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.