Safety and Efficacy of the SurVeil™ Drug-Coated Balloon

NCT03241459 | Completed Results DMC FDA Device

• 1 other identifier: SUR17-001
• Study Type: interventional
• Target: 446
• Locations: 8 countries
• Sites: 62

Brief Summary

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.

Conditions

Peripheral Arterial Disease; Peripheral Vascular Disease; Artery Disease, Peripheral; Femoropopliteal Artery Occlusion

Keywords

Percutaneous Transluminal Angioplasty; PTA; Peripheral Artery Disease; PAD; Paclitaxel

Outcome Measures

Primary Outcomes (2)

• Primary Lesion Patency Though 12 Months

  Composite of freedom from clinically-driven target lesion revascularization (TLR) and binary restenosis (restenosis defined as duplex ultrasound \[DUS\] peak systolic velocity ratio \[PSVR\] ≥2.4 or ≥50% stenosis as assessed by independent angiographic and DUS core labs) through 12 months post-index procedure.

  12 months

• Safety Composite of Freedom From Death, Amputation, and Target Vessel Revascularization (TVR)

  Composite of freedom from device- and procedure-related death through 30 days post-index procedure and freedom from major target limb amputation (above the ankle) and clinically-driven TVR through 12 months post-index procedure.

  12 months

Secondary Outcomes (21)

• Proportion of Participants With Device Success

  Day 0

• Proportion of Participants With Technical Success

  Day 0

• Proportion of Participants With Procedure Success

  72 hours

• Freedom From All-cause Death, Major Target Limb Amputation and TVR Through 30 Days

  30 days

• Proportion of Participants With Primary Lesion Patency

  24 months

Study Arms (2)

Surmodics SurVeil DCB

EXPERIMENTAL

Surmodics SurVeil Drug-Coated Balloon is an investigational device coated with paclitaxel.

Device: Surmodics SurVeil DCB

Medtronic IN.PACT Admiral DCB

ACTIVE COMPARATOR

Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.

Device: Medtronic IN.PACT Admiral DCB

Interventions

Surmodics SurVeil DCB DEVICE

Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.

Surmodics SurVeil DCB

Medtronic IN.PACT Admiral DCB DEVICE

Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.

Medtronic IN.PACT Admiral DCB

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• SurModics, Inc.: lead

Study Sites (63)

Cardiovascular Associates of the Southeast

Birmingham, Alabama, 35243, United States

Location

Cardiology Associates

Foley, Alabama, 36535, United States

Location

Dignity Health

Gilbert, Arizona, 85297, United States

Location

Yuma Regional Medical Center

Yuma, Arizona, 85364, United States

Location

Mission Cardiovascular Research Institute

Fremont, California, 94538, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Clearwater Cardiovascular Consultants

Clearwater, Florida, 33756, United States

Location

Advent Health Ocala/MediQuest Research Group LLC (formerly FL Hospital /Munroe)

Ocala, Florida, 34478, United States

Location

Piedmont Heart Insitute

Atlanta, Georgia, 30309, United States

Location

Emory University Hospital (Clifton)

Atlanta, Georgia, 30322, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Alexian Brothers Medical Center

Elk Grove Village, Illinois, 60007, United States

Location

Advocate Health

Naperville, Illinois, 60540, United States

Location

Prairie Education (PERC)

Springfield, Illinois, 62701, United States

Location

St Vincent Heart (Research Department)

Indianapolis, Indiana, 46290, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Endovascular Technologies, LLC

Bossier City, Louisiana, 71111, United States

Location

Cardiovascular Associates Research

Covington, Louisiana, 70433, United States

Location

St. Elizabeth's Medical Center

Boston, Massachusetts, 02135, United States

Location

Beth Israel Deaconess

Boston, Massachusetts, 02215, United States

Location

Northern Michigan Hospital

Petoskey, Michigan, 49770, United States

Location

North Memorial Hospital

Robbinsdale, Minnesota, 55422, United States

Location

Hattiesburg Clinic

Hattiesburg, Mississippi, 39401, United States

Location

Mercy Hospital

Springfield, Missouri, 65804, United States

Location

University of Nebraska

Omaha, Nebraska, 68198, United States

Location

Virtua Medical Group, P.A.

Cherry Hill, New Jersey, 08034, United States

Location

St. Michael's Hospital

Newark, New Jersey, 07102, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

Location

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

Moses Cone-LeBauer

Greensboro, North Carolina, 27401, United States

Location

North Carolina Heart and Vascular

Raleigh, North Carolina, 27607, United States

Location

The Lindner Clinical Trial Center

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

North Ohio Heart Center

Elyria, Ohio, 44035, United States

Location

University of Toledo Medical Center

Toledo, Ohio, 43614, United States

Location

Oklahoma Cardiovascular Research Group

Oklahoma City, Oklahoma, 73120, United States

Location

Providence Heart and Vascular

Portland, Oregon, 97225, United States

Location

Capital Area Research

Camp Hill, Pennsylvania, 17011, United States

Location

Bryn Mawr Hospital - Main Line Health System (Einstein)

Philadelphia, Pennsylvania, 19141, United States

Location

Pinnacle Health Cardiovascular Institute

Wormleysburg, Pennsylvania, 17043, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Ballad Health System

Kingsport, Tennessee, 37660, United States

Location

Turkey Creek Medical Center

Knoxville, Tennessee, 37934, United States

Location

St. David's Heart & Vascular PLLC dba Austin Heart

Austin, Texas, 78756, United States

Location

Houston Cardiovascular Association

Houston, Texas, 77030, United States

Location

North Dallas Research Associates

McKinney, Texas, 75069, United States

Location

Prince of Wales Private Hostpital

Randwick, Australia

Location

Institution Medizinische Universitat

Graz, Austria

Location

AZ Sint Blasius

Dendermonde, Belgium

Location

UZ GENT

Ghent, Belgium

Location

FN u sv. Anny v Brně a LF MU (Centrum cévních onemocnění II. chirurgická klinika)

Brno, Czechia

Location

Vitkovicka Nemocnice Ostrava Vítkovická nemocnice, a.s.,

Ostrava, Czechia

Location

Herz Zentrum Bad Krozingen Südring

Bad Krozingen, Germany

Location

SRH Klinikum KarlsbadLangensteinbach

Karlsbad, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Germany

Location

REGIOMED-KLINIKEN GmbH

Sonneberg, Germany

Location

Aou Careggi University Hospital

Florence, Italy

Location

Pauls Stradins Clinical University Hospital

Riga, Latvia

Location

Auckland City Hospital

Auckland, New Zealand

Location

Related Publications (7)

• 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.

  PMID: 16549646 BACKGROUND

• 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.

  PMID: 17140820 BACKGROUND

• 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.

  PMID: 26476467 BACKGROUND

• 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.

  PMID: 26106946 BACKGROUND

• 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.

  PMID: 25744011 BACKGROUND

• 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.

  PMID: 39615582 DERIVED

• 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.

  PMID: 30685679 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Kimberly Hawkinson
• Organization: Surmodics

khawkinson@surmodics.com

952-500-7563

Study Officials

• William Gray, MD

  Lankenau Heart Group

  PRINCIPAL INVESTIGATOR

• Kenneth Rosenfield, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Marianne Brodmann, MD

  Medical University Graz, Department of Internal Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 7, 2017
• Study Start: October 23, 2017
• Primary Completion: September 15, 2020
• Study Completion: September 17, 2024
• Last Updated: March 25, 2025
• Results First Posted: April 9, 2024

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1); US (50); AU (1); BE (2); CZ (2); DE (4); LA (1); IT (1)