Peripheral Arterial Disease
Conditions
Keywords
Peripheral Vascular Disease, Critical Limb Ischemia, Superficial Femoral Artery Stenosis, Atherosclerosis, Arteriosclerosis, Vascular Diseases, Arterial Disease Occlusive, lower extremity arterial disease
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.
Interventions
DEVICEAxys EX device
Rotational atherectomy system for endovascular treatment of peripheral arterial disease prior to adjunctive therapy, if needed
Sponsors
Medtronic Endovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: 1. Rutherford Clinical Category (RCC) Score of 2 - 5 2. Willing and capable of complying with all follow-up evaluations at the specified times 3. Age ≥ 18 years old 4. Provides written informed consent prior to study specific procedures 5. Completed Ankle/Brachial Index (ABI) (or Toe/Brachial Index \[TBI\]) prior to index procedure (up to 60 days prior) Angiographic Inclusion Criteria: 6. Evidence of ≥ 70% stenosis or occlusion in the peripheral vasculature of the target vessel, confirmed by angiography 7. 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: 1. 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 2. Combination Lesion: A single lesion that is not completely occluded but includes a segment of complete occlusion anywhere along the length 8. Exchangeable guidewire must cross target lesion within the lumen 9. Total target lesion length is ≥ 20 mm and ≤ 200mm 10. Reference vessel diameter (RVD) is ≥ 2.0 mm and ≤ 5.0 mm 11. 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) 12. Multiple lesions in the target limb (including the target lesion and non-target lesions) may be treated if all of the following applies: 1. Non-target lesion(s) must be located proximal to the target lesion 2. 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 3. Non-target lesions treated prior to target lesion cannot be treated with rotational, orbital or laser atherectomy 4. 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.) 5. Only one lesion per the above definitions may be treated as the target lesion with the Axys EX device General
Exclusion criteria
13. Has one or more of the contraindications listed in the Axys EX Rotational Atherectomy System's IFU 14. Contraindication or known untreated allergy to antiplatelet therapy, anticoagulants, thrombolytic drugs, or any other drug anticipated to be used 15. Hypersensitivity to contrast material that cannot be adequately pretreated 16. Known uncontrollable hypercoagulable condition or refuses blood transfusion 17. Life expectancy of less than 12 months 18. Surgical (requiring hospitalization) or endovascular intervention of the target limb within 30 days prior to the index procedure 19. Planned surgical intervention or endovascular procedure within 30 days after the index procedure 20. Currently participating in an investigational drug or another device study that may clinically interfere with the study endpoints 21. Other co-morbid condition(s) that in the judgment of the physician precludes safe percutaneous intervention 22. 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 23. Impaired renal function (defined as GFR \< 30 mL/min) or on dialysis 24. Recent myocardial infarction or stroke ≤ 30 days prior to the index procedure 25. Previous or planned amputation above the metatarsal line on the target limb 26. 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 27. Patient is pregnant (female patients of child-bearing potential must have a pregnancy test done within 7 days prior to the index procedure) Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1. 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) 2. 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) |
| 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 |
| 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. |
| Quality of Life Assessment | 30-Days, 6 and 12-Months | EQ-5D questionnaire |
| 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 |
Outcome results
None listed