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Compares treatment options for Peripheral Arterial Diseases
Official title Auryon Atherectomy System With Standard Balloon Angioplasty Versus Standard Balloon Angioplasty Alone
ClinicalTrials.gov ID: NCT06777901
What this study is testing
- What it's testing
- The goal of this clinical trial is to learn if the Auryon Atherectomy System with balloon angioplasty safe and effective in treating lower limb blockages. The main question it aims to answer is: Is treatment with Auryon Atherectomy System more effective than angioplasty alone in preventing death, amputation, revascularization and improving patency?
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Adults
You may be able to join if
- Age of subject is ≥ 18.
- Estimated life expectancy ≥1 year.
- Subject is able and willing to comply with all assessments in the study.
- Subject has been informed of the nature of the study, agrees to participate, and has signed the approved consent form.
- Rutherford Category classification of 4 or 5 of the target limb.
You likely can't join if
- Target lesion is in a vessel graft or synthetic graft.
- Treatment of target lesion with radial access.
- Planned target limb major amputation (above-the-ankle).
- Acute limb ischemia or required thrombolysis as a primary treatment modality of the target limb.
- 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...
- Subject is pregnant or breastfeeding. (Female people of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days...
See the full eligibility criteria
Who can join
- Age of subject is ≥ 18.
- Estimated life expectancy ≥1 year.
- Subject is able and willing to comply with all assessments in the study.
- Subject has been informed of the nature of the study, agrees to participate, and has signed the approved consent form.
- Rutherford Category classification of 4 or 5 of the target limb.
- Subject is a suitable candidate for angiography and endovascular intervention in the opinion of the investigator or per hospital guidelines. Angiographic Target lesion that is located in a native, de novo...
- Target lesions(s) must be viewed angiographically and have 50-100% stenosis.
- Only a single lesion is included in the study per subject.
- The vessel segment distal to the target lesion must be patent all the way to the ankle, with no significant lesion (≥ 50% stenosis).
- Lesion length ≥50mm and ≤300mm.
- 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...
- Target Lesion reference vessel diameter (RVD) between 1.5mm - 4.5mm by investigator estimate.
What rules you out
- Target lesion is in a vessel graft or synthetic graft.
- Treatment of target lesion with radial access.
- Planned target limb major amputation (above-the-ankle).
- Acute limb ischemia or required thrombolysis as a primary treatment modality of the target limb.
- 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.
- Subject is pregnant or breastfeeding. (Female people of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure.)
- Subject has a known coagulopathy or has bleeding diatheses/disorder, thrombocytopenia with platelet count less than 100,000/microliter / less than 80,000K.
- Subject in whom antiplatelet or anticoagulant therapy is contraindicated.
- Subject has known allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated.
- Myocardial infarction within 60 days prior to enrollment.
- History of stroke/CVA/TIA within 60 days prior to enrollment.
- History of thrombolytic therapy within 14 days of enrollment.
- Subject has acute or chronic renal disease defined as serum creatinine of \>2.5 mg/dL or \>220 umol/L, or is on dialysis.
- Subject is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint.
- 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.
- Subject experiencing ongoing cardiac problems that per the investigator judgment would not make the subject ideal per the procedure.
- Subject has evidence of intracranial or gastrointestinal bleeding within the past 3 months. Angiographic Exclusion Criteria
- Failure to treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or P1-P2 segments of the popliteal arteries with \<50% residual stenosis with no serious angiographic complications (e.g...
- Residual stenosis, and/or serious angiographic complications (e.g., embolism) prior to the investigational device usage.
- The use of adjunctive devices to treat the target lesion other than the investigative Auryon laser catheter and/or PTA devices, such as scoring balloons, drug-eluting balloons, re-entry devices, lithotripsy devices, or...
- people intended to be treated with the Auryon Atherectomy System for de-novo, restenotic or ISR lesions of the infra-popliteal arteries.
- people presenting with symptomatic PAD with claudication or CLI by Rutherford Category 2 - 6 of the target limb.
- Age of subject is ≥ 18.
- Subject has been informed of the nature of the study, agrees to participate, and has signed the approved study consent form. Observational Study Exclusion Criteria:
- people with any medical condition that would make him/her an inappropriate candidate for treatment with Auryon Atherectomy System as per Instructions for Use (IFU) or investigator's opinion.
- Subject is pregnant or breastfeeding. (Female people of childbearing potential must be non-breastfeeding and have a negative pregnancy test ≤ 7 days before the procedure.)
- Subject is already enrolled in other investigational (treatment) studies that would interfere with study endpoints.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- San Diego, California, United States
- Gray, Louisiana, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- St Louis, Missouri, United States
- Chapel Hill, North Carolina, United States
- Cleveland, Ohio, United States
- Greenville, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, not specified. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; San Diego, California, United States; Gray, Louisiana, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; St Louis, Missouri, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.