Safety and Efficacy of the SurVeil™ Drug-Coated Balloon

Completed · Not applicable

Conditions studied: Peripheral Arterial Disease, Peripheral Vascular Disease, Artery Disease, Peripheral, Femoropopliteal Artery Occlusion

In brief

To demonstrate the safety and efficacy of the SurVeil Drug-Coated Balloon (DCB) for treatment of subjects with symptomatic peripheral artery disease (PAD) due to stenosis of the femoral and/or popliteal arteries.

Key facts

Study ID: NCT03241459
Run by: SurModics, Inc.
People needed: 446
Starts: 2017-10-23
Expected to finish: 2024-09-17
Last updated by the study team: 2025-03-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject is ≥18 years.
Subject has target limb Rutherford classification 2, 3 or 4.
Subject has provided written informed consent and is willing to comply with study follow-up requirements.
De novo lesion(s) or non-stented restenotic lesion(s) occurring >90 days after prior plain old balloon (POBA) angioplasty or >180 days after prior DCB treatment.
Target lesion location starts ≥10 mm below the common femoral bifurcation and terminates distally at or above the end of the P1 segment of the popliteal artery.
Target vessel diameter ≥4 mm and ≤7 mm.
Target lesion must have angiographic evidence of ≥70% stenosis by operator visual estimate.
Chronic total occlusions may be included only after successful, uncomplicated wire crossing of target lesion via an anterograde approach and without the use of subintimal dissection techniques.
Target lesion must be ≤180 mm in length (one long lesion or multiple serial lesions) by operator visual estimate. Note: combination lesions must have a total lesion length of ≤180 mm by visual estimate and be separated by ≤30 mm.
Target lesion is located at least 30 mm from any stent, if target vessel was previously stented.
Successful, uncomplicated (without use of a crossing device) wire crossing of target lesion. Successful crossing of the target lesion occurs when the tip of the guide wire is distal to the target lesion without the occurrence of flow-limiting dissection or perforation and is judged by visual inspection to be within the true lumen.
After pre-dilatation, the target lesion is ≤70% residual stenosis, absence of a flow limiting dissection and treatable with available device matrix.
A patent inflow artery free from significant stenosis (≥50% stenosis) as confirmed by angiography.
At least one patent native outflow artery to the ankle or foot, free from significant stenosis (≥50% stenosis) as confirmed by angiography.

You may not qualify if…

Subject has acute limb ischemia.
Subject underwent percutaneous transluminal angioplasty (PTA) of the target limb using plain old balloon angioplasty (POBA) or a stent within the previous 90 days.
Subject underwent any lower extremity percutaneous treatment using a paclitaxel-eluting stent or a DCB within the previous 90 days.
Subject underwent PTA of the target lesion using a DCB within the previous 180 days.
Subject has had prior vascular intervention in the contralateral limb within 14 days before the planned study index procedure or subject has planned vascular intervention in the contralateral limb within 30 days after the index procedure.
Subject is pregnant, breast-feeding or intends to become pregnant during the time of the study.
Subject has life expectancy less than 2 years.
Subject has a known allergy to contrast medium that cannot be adequately pre-medicated.
Subject is allergic to ALL antiplatelet treatments.
Subject has impaired renal function (i.e. serum creatinine level ≥2.5 mg/dL).
Subject is dialysis dependent.
Subject is receiving immunosuppressant therapy.
Subject has known or suspected active infection at the time of the index procedure.
Subject has platelet count <100,000/mm3 or >700,000/mm3.
Subject has history of gastrointestinal hemorrhage requiring a transfusion within 3 months prior to the study procedure.
Subject is diagnosed with coagulopathy that precludes treatment with systemic anticoagulation and/or dual antiplatelet therapy (DAPT).
Subject has history of stroke within the past 90 days.
Subject has a history of myocardial infarction within the past 30 days.
Subject is unable to tolerate blood transfusions because of religious beliefs or other reasons.
Subject is incarcerated, mentally incompetent, or abusing drugs or alcohol.
Subject is participating in another investigational drug or medical device study that has not completed primary endpoint(s) evaluation or that clinically interferes with the endpoints from this study, or subject is planning to participate in such studies prior to the completion of this study.
Subject has had any major (e.g. cardiac, peripheral, abdominal) surgical procedure or intervention unrelated to this study within 30 days prior to the index procedure or has planned major surgical procedure or intervention within 30 days of the index procedure.
Subject had previous bypass surgery of the target lesion.
Subject had previous treatment of the target vessel with thrombolysis or surgery.
Subject is unwilling or unable to comply with procedures specified in the protocol or has difficulty or inability to return for follow-up visits as specified by the protocol.

Where it is running

Cardiology Associates — Foley, Alabama, United States
Dignity Health — Gilbert, Arizona, United States
Yuma Regional Medical Center — Yuma, Arizona, United States
Mission Cardiovascular Research Institute — Fremont, California, United States
Yale New Haven Hospital — New Haven, Connecticut, United States
MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
Clearwater Cardiovascular Consultants — Clearwater, Florida, United States
Advent Health Ocala/MediQuest Research Group LLC (formerly FL Hospital /Munroe) — Ocala, Florida, United States
Piedmont Heart Insitute — Atlanta, Georgia, United States
Emory University Hospital (Clifton) — Atlanta, Georgia, United States
Northeast Georgia Medical Center — Gainesville, Georgia, United States
Alexian Brothers Medical Center — Elk Grove Village, Illinois, United States
Advocate Health — Naperville, Illinois, United States
Prairie Education (PERC) — Springfield, Illinois, United States
St Vincent Heart (Research Department) — Indianapolis, Indiana, United States
Iowa Heart Center — West Des Moines, Iowa, United States
University of Kansas Medical Center — Kansas City, Kansas, United States
Endovascular Technologies, LLC — Bossier City, Louisiana, United States
Cardiovascular Associates Research — Covington, Louisiana, United States
St. Elizabeth's Medical Center — Boston, Massachusetts, United States
Beth Israel Deaconess — Boston, Massachusetts, United States
Northern Michigan Hospital — Petoskey, Michigan, United States
North Memorial Hospital — Robbinsdale, Minnesota, United States
Hattiesburg Clinic — Hattiesburg, Mississippi, United States
Cardiovascular Associates of the Southeast — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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