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RANDOMIZED CONTROLLED TRIAL OF THE AURYON ATHERECTOMY SYSTEM USED IN COMBINATION WITH STANDARD BALLOON ANGIOPLASTY VERSUS STANDARD BALLOON ANGIOPLASTY ALONE TREATING INFRAPOPLITEAL LESIONS IN SUBJECTS WITH CRITICAL LIMB ISCHEMIA: the Auryon AMBITION BTK RCT / Registry

This is a multi-center, prospective, randomized (1:1) controlled trial (RCT) comparing the clinical outcomes of Auryon Atherectomy System and percutaneous transluminal balloon angioplasty (PTA) (treatment group) versus PTA alone (control group) to treat subjects with infra-popliteal peripheral arterial disease (PAD) defined as Rutherford Classification 4 or 5.

The observational registry study (OS) is a prospective, multi-center, single arm observational study for subjects with infrainguinal peripheral artery disease treated with the Auryon Atherectomy System, who do not meet the inclusion/exclusion criteria of the randomized study or for subjects who are recruited after enrollment in the randomized study is complete. Investigators will complete documented training provided by AngioDynamics prior to enrollment in the RCT.

Inclusion

A potential subject will be included in the study if they meet all of the following inclusion criteria:

1. Age of subject is ≥ 18.
2. Estimated life expectancy ≥1 year.
3. Subject is able and willing to comply with all assessments in the study.
4. Subject has been informed of the nature of the study, agrees to participate, and has signed the approved consent form.
5. Rutherford Category classification of 4 or 5 of the target limb.
6. Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guidelines.
7. Female subjects of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure.

Angiographic Inclusion Criteria

1. Target lesion that is located in a native, de novo infra-popliteal artery (popliteal artery extends to and ends proximal to the ostium of the anterior tibial artery).
2. Target lesions(s) must be viewed angiographically and have ≥50% stenosis.
3. Chronic total occlusions are allowed.
4. A single lesion is allowed per subject.
5. The distal margin of the target lesion must be located ≥ 10 cm proximal to the proximal margin of the ankle mortise. The vessel segment distal to the target lesion must be patent all the way to the ankle, with no significant lesion (≥ 50% stenosis).
6. Lesion length ≥50mm and ≤300mm.
7. Intraluminal crossing of the lesion. Successful crossing is defined as tip of the guidewire distal to the target lesion in the absence of flow limiting dissections or perforations. If this is not certain, IVUS or OCT may be used to verify this at the operator’s discretion.
8. Target Lesion reference vessel diameter (RVD) between 1.5mm - 4.5mm by investigator estimate.
9. Subject has at least one patent tibial vessel on the target leg with 2-vessel runoff to the foot, defined as stenosis ≤50%.

Exclusion

A potential subject will be excluded from the study if they meet any of the following exclusion criteria:
1. Target lesion is in a vessel graft or synthetic graft.
2. Treatment of target lesion with radial access.
3. Subject has active infection requiring antibiotic therapy.
4. Planned target limb major amputation (above-the-ankle).
5. Acute limb ischemia or required thrombolysis as a primary treatment modality of the target limb.
6. History of prior endovascular or surgical procedure on the index limb within 30 days prior to enrollment or planned within 30 days of the index procedure.
7. Subject is pregnant or breastfeeding
8. Subject has a known coagulopathy or has bleeding diatheses/disorder, thrombocytopenia with platelet count less than 100,000/microliter / less than 80,000K.
9. Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
10. Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
11. Myocardial infarction within 60 days prior to enrollment.
12. History of stroke/CVA/TIA within 60 days prior to enrollment.
13. History of thrombolytic therapy within 14 days of enrollment.
14. Subject has acute or chronic renal disease defined as serum creatinine of >2.5 mg/dL or >220 umol/L, or is on dialysis.
15. Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
16. Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the study requirements and evaluations pre- and post-treatment.
17. The use of drug-eluting balloons, re-entry or other atherectomy devices.
18. Subject experiencing ongoing cardiac problems that per the investigator judgment would not make the subject ideal per the procedure.
19. Subject has evidence of intracranial or gastrointestinal bleeding within the past 3 months.

Angiographic Exclusion Criteria

1. Failure to treat clinically significant inflow lesions in the contralateral iliac, ipsilateral iliac, femoral, or P1-P2 segments of the popliteal arteries with ≤30
2. residual stenosis, and/or serious angiographic complications (e.g., embolism) prior to the investigational device usage.
3. Failure to perioperatively successfully treat significant non-target infra-popliteal lesions prior to treatment of the target lesion (during the index procedure). Successful treatment is defined as obtaining ≤50% residual stenosis with no serious angiographic complications (e.g., embolism).