Safety and Efficacy of the SurVeil™ Drug-Coated Balloon
NCT ID: NCT03241459
Last Updated: 2025-03-25
Study Results
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View full resultsBasic Information
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COMPLETED
NA
446 participants
INTERVENTIONAL
2017-10-23
2024-09-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Surmodics SurVeil DCB
Surmodics SurVeil Drug-Coated Balloon is an investigational device coated with paclitaxel.
Surmodics SurVeil DCB
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
Medtronic IN.PACT Admiral DCB
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
Medtronic IN.PACT Admiral DCB
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
Interventions
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Surmodics SurVeil DCB
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
Medtronic IN.PACT Admiral DCB
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* Target lesion has severe calcification (as defined by the PARC classification of calcification).
* Target lesion involves an aneurysm or is adjacent to an aneurysm (within 5 mm).
* Target lesion requires treatment with alternative therapy such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices, or subintimal dissection techniques.
* Significant target vessel tortuosity or other parameters prohibiting access to the target lesion.
* Presence of thrombus in the target vessel.
* Iliac inflow disease requiring treatment, unless the iliac artery disease is successfully treated first during the index procedure. Success is defined as ≤30% residual diameter stenosis without death or major complications.
* Presence of an aortic, iliac or femoral artificial graft.
18 Years
ALL
No
Sponsors
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SurModics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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William Gray, MD
Role: PRINCIPAL_INVESTIGATOR
Lankenau Heart Group
Kenneth Rosenfield, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Marianne Brodmann, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University Graz, Department of Internal Medicine
Locations
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Cardiovascular Associates of the Southeast
Birmingham, Alabama, United States
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
Mercy Hospital
Springfield, Missouri, United States
University of Nebraska
Omaha, Nebraska, United States
Virtua Medical Group, P.A.
Cherry Hill, New Jersey, United States
St. Michael's Hospital
Newark, New Jersey, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
Columbia University Medical Center/NYPH
New York, New York, United States
Mission Hospital
Asheville, North Carolina, United States
Moses Cone-LeBauer
Greensboro, North Carolina, United States
North Carolina Heart and Vascular
Raleigh, North Carolina, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio Health Research Institute
Columbus, Ohio, United States
North Ohio Heart Center
Elyria, Ohio, United States
University of Toledo Medical Center
Toledo, Ohio, United States
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, United States
Providence Heart and Vascular
Portland, Oregon, United States
Capital Area Research
Camp Hill, Pennsylvania, United States
Bryn Mawr Hospital - Main Line Health System (Einstein)
Philadelphia, Pennsylvania, United States
Pinnacle Health Cardiovascular Institute
Wormleysburg, Pennsylvania, United States
The Miriam Hospital
Providence, Rhode Island, United States
Ballad Health System
Kingsport, Tennessee, United States
Turkey Creek Medical Center
Knoxville, Tennessee, United States
St. David's Heart & Vascular PLLC dba Austin Heart
Austin, Texas, United States
Houston Cardiovascular Association
Houston, Texas, United States
North Dallas Research Associates
McKinney, Texas, United States
Prince of Wales Private Hostpital
Randwick, , Australia
Institution Medizinische Universitat
Graz, , Austria
AZ Sint Blasius
Dendermonde, , Belgium
UZ GENT
Ghent, , Belgium
FN u sv. Anny v Brně a LF MU (Centrum cévních onemocnění II. chirurgická klinika)
Brno, , Czechia
Vitkovicka Nemocnice Ostrava Vítkovická nemocnice, a.s.,
Ostrava, , Czechia
Herz Zentrum Bad Krozingen Südring
Bad Krozingen, , Germany
SRH Klinikum KarlsbadLangensteinbach
Karlsbad, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
REGIOMED-KLINIKEN GmbH
Sonneberg, , Germany
Aou Careggi University Hospital
Florence, , Italy
Pauls Stradins Clinical University Hospital
Riga, , Latvia
Auckland City Hospital
Auckland, , New Zealand
Countries
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References
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Hirsch AT, Haskal ZJ, Hertzer NR, Bakal CW, Creager MA, Halperin JL, Hiratzka LF, Murphy WR, Olin JW, Puschett JB, Rosenfield KA, Sacks D, Stanley JC, Taylor LM Jr, White CJ, White J, White RA, Antman EM, Smith SC Jr, Adams CD, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Hunt SA, Jacobs AK, Nishimura R, Ornato JP, Page RL, Riegel B; American Association for Vascular Surgery; Society for Vascular Surgery; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society of Interventional Radiology; ACC/AHA Task Force on Practice Guidelines Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease; American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; Vascular Disease Foundation. ACC/AHA 2005 Practice Guidelines for the management of patients with peripheral arterial disease (lower extremity, renal, mesenteric, and abdominal aortic): a collaborative report from the American Association for Vascular Surgery/Society for Vascular Surgery, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, Society of Interventional Radiology, and the ACC/AHA Task Force on Practice Guidelines (Writing Committee to Develop Guidelines for the Management of Patients With Peripheral Arterial Disease): endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation; National Heart, Lung, and Blood Institute; Society for Vascular Nursing; TransAtlantic Inter-Society Consensus; and Vascular Disease Foundation. Circulation. 2006 Mar 21;113(11):e463-654. doi: 10.1161/CIRCULATIONAHA.106.174526. No abstract available.
Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG; TASC II Working Group; Bell K, Caporusso J, Durand-Zaleski I, Komori K, Lammer J, Liapis C, Novo S, Razavi M, Robbs J, Schaper N, Shigematsu H, Sapoval M, White C, White J, Clement D, Creager M, Jaff M, Mohler E 3rd, Rutherford RB, Sheehan P, Sillesen H, Rosenfield K. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surg. 2007;33 Suppl 1:S1-75. doi: 10.1016/j.ejvs.2006.09.024. Epub 2006 Nov 29. No abstract available.
Laird JR, Schneider PA, Tepe G, Brodmann M, Zeller T, Metzger C, Krishnan P, Scheinert D, Micari A, Cohen DJ, Wang H, Hasenbank MS, Jaff MR; IN.PACT SFA Trial Investigators. Durability of Treatment Effect Using a Drug-Coated Balloon for Femoropopliteal Lesions: 24-Month Results of IN.PACT SFA. J Am Coll Cardiol. 2015 Dec 1;66(21):2329-2338. doi: 10.1016/j.jacc.2015.09.063. Epub 2015 Oct 14.
Rosenfield K, Jaff MR, White CJ, Rocha-Singh K, Mena-Hurtado C, Metzger DC, Brodmann M, Pilger E, Zeller T, Krishnan P, Gammon R, Muller-Hulsbeck S, Nehler MR, Benenati JF, Scheinert D; LEVANT 2 Investigators. Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease. N Engl J Med. 2015 Jul 9;373(2):145-53. doi: 10.1056/NEJMoa1406235. Epub 2015 Jun 24.
Patel MR, Conte MS, Cutlip DE, Dib N, Geraghty P, Gray W, Hiatt WR, Ho M, Ikeda K, Ikeno F, Jaff MR, Jones WS, Kawahara M, Lookstein RA, Mehran R, Misra S, Norgren L, Olin JW, Povsic TJ, Rosenfield K, Rundback J, Shamoun F, Tcheng J, Tsai TT, Suzuki Y, Vranckx P, Wiechmann BN, White CJ, Yokoi H, Krucoff MW. Evaluation and treatment of patients with lower extremity peripheral artery disease: consensus definitions from Peripheral Academic Research Consortium (PARC). J Am Coll Cardiol. 2015 Mar 10;65(9):931-41. doi: 10.1016/j.jacc.2014.12.036.
Brodmann M, Gray WA, Schneider PA, Kurzmann-Guetl K, Schweiger L, Zeller T, Thieme M, Kilaru S, Bachinsky WB, Feldman RL, Holden A, Varcoe RL, Lansky AJ, Rosenfield K; TRANSCEND Study Investigators. Editor's Choice - Results of SurVeil Versus IN.PACT Admiral Paclitaxel Coated Balloons in Femoropopliteal Arteries: 24 Month Outcomes of the Randomised TRANSCEND Study. Eur J Vasc Endovasc Surg. 2025 Mar;69(3):452-462. doi: 10.1016/j.ejvs.2024.11.351. Epub 2024 Nov 29.
Elmariah S, Ansel GM, Brodmann M, Doros G, Fuller S, Gray WA, Pinto DS, Rosenfield KA, Mauri L. Design and rationale of a randomized noninferiority trial to evaluate the SurVeil drug-coated balloon in subjects with stenotic lesions of the femoropopliteal artery - the TRANSCEND study. Am Heart J. 2019 Mar;209:88-96. doi: 10.1016/j.ahj.2018.12.012. Epub 2018 Dec 28.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SUR17-001
Identifier Type: -
Identifier Source: org_study_id
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