Safety and Efficacy of the SurVeil™ Drug-Coated Balloon (TRANSCEND)

Randomized & Controlled Noninferiority Trial to Evaluate Safety & Clinical Efficacy of SurVeil™ Drug-Coated Balloon (DCB) iN Treatment of Subjects With Stenotic Lesions of Femoropopliteal Artery Compared to Medtronic IN.PACT® Admiral® DCB

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Peripheral Vascular Disease; Femoropopliteal Artery Occlusion; Artery Disease, Peripheral
• Intervention / Treatment: Device: Surmodics SurVeil DCB; Device: Medtronic IN.PACT Admiral DCB

Detailed Description

TRANSCEND is a prospective, multi-center, single-blind, randomized, controlled, noninferiority clinical trial. The trial will randomize approximately 446 subjects with symptomatic PAD due to stenoses of the femoral and/or popliteal arteries. Subjects meeting eligibility criteria will be randomized 1:1 to treatment with either the SurVeil DCB or the IN.PACT Admiral DCB, and followed for 60 months.

• Study Type: Interventional
• Enrollment (Actual): 446
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Randwick, Australia
    • Prince of Wales Private Hostpital
• Austria
  • Graz, Austria
    • Institution Medizinische Universitat
• Belgium
  • Dendermonde, Belgium
    • AZ Sint Blasius
  • Ghent, Belgium
    • Uz Gent
• Czechia
  • Brno, Czechia
    • FN u sv. Anny v Brně a LF MU (Centrum cévních onemocnění II. chirurgická klinika)
  • Ostrava, Czechia
    • Vitkovicka Nemocnice Ostrava Vítkovická nemocnice, a.s.,
• Germany
  • Bad Krozingen, Germany
    • Herz Zentrum Bad Krozingen Südring
  • Karlsbad, Germany
    • SRH Klinikum KarlsbadLangensteinbach
  • Leipzig, Germany
    • Universitätsklinikum Leipzig
  • Sonneberg, Germany
    • REGIOMED-KLINIKEN GmbH
• Italy
  • Florence, Italy
    • Aou Careggi University Hospital
• Latvia
  • Riga, Latvia
    • Pauls Stradins Clinical University Hospital
• New Zealand
  • Auckland, New Zealand
    • Auckland City Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35243
      • Cardiovascular Associates of the Southeast
    • Foley, Alabama, United States, 36535
      • Cardiology Associates
  • Arizona
    • Gilbert, Arizona, United States, 85297
      • Dignity Health
    • Yuma, Arizona, United States, 85364
      • Yuma Regional Medical Center
  • California
    • Fremont, California, United States, 94538
      • Mission Cardiovascular Research Institute
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale New Haven Hospital
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Medstar Washington Hospital Center
  • Florida
    • Clearwater, Florida, United States, 33756
      • Clearwater Cardiovascular Consultants
    • Ocala, Florida, United States, 34478
      • Advent Health Ocala/MediQuest Research Group LLC (formerly FL Hospital /Munroe)
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Insitute
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital (Clifton)
    • Gainesville, Georgia, United States, 30501
      • Northeast Georgia Medical Center
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007
      • Alexian Brothers Medical Center
    • Naperville, Illinois, United States, 60540
      • Advocate Health
    • Springfield, Illinois, United States, 62701
      • Prairie Education (PERC)
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • St Vincent Heart (Research Department)
  • Iowa
    • West Des Moines, Iowa, United States, 50266
      • Iowa Heart Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Louisiana
    • Bossier City, Louisiana, United States, 71111
      • Endovascular Technologies, LLC
    • Covington, Louisiana, United States, 70433
      • Cardiovascular Associates Research
  • Massachusetts
    • Boston, Massachusetts, United States, 02135
      • St. Elizabeth's Medical Center
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess
  • Michigan
    • Petoskey, Michigan, United States, 49770
      • Northern Michigan Hospital
  • Minnesota
    • Robbinsdale, Minnesota, United States, 55422
      • North Memorial Hospital
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic
  • Missouri
    • Springfield, Missouri, United States, 65804
      • Mercy Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08034
      • Virtua Medical Group, P.A.
    • Newark, New Jersey, United States, 07102
      • St. Michael's Hospital
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Medical Center
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center/NYPH
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Mission Hospital
    • Greensboro, North Carolina, United States, 27401
      • Moses Cone-LeBauer
    • Raleigh, North Carolina, United States, 27607
      • North Carolina Heart and Vascular
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • The Lindner Clinical Trial Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43214
      • Ohio Health Research Institute
    • Elyria, Ohio, United States, 44035
      • North Ohio Heart Center
    • Toledo, Ohio, United States, 43614
      • University of Toledo Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma Cardiovascular Research Group
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Heart and Vascular
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • Capital Area Research
    • Philadelphia, Pennsylvania, United States, 19141
      • Bryn Mawr Hospital - Main Line Health System (Einstein)
    • Wormleysburg, Pennsylvania, United States, 17043
      • Pinnacle Health Cardiovascular Institute
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • The Miriam Hospital
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
      • Ballad Health System
    • Knoxville, Tennessee, United States, 37934
      • Turkey Creek Medical Center
  • Texas
    • Austin, Texas, United States, 78756
      • St. David's Heart & Vascular PLLC dba Austin Heart
    • Houston, Texas, United States, 77030
      • Houston Cardiovascular Association
    • McKinney, Texas, United States, 75069
      • North Dallas Research Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surmodics SurVeil DCB; Surmodics SurVeil Drug-Coated Balloon is an investigational device coated with paclitaxel.	Device: Surmodics SurVeil DCB; Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
Active Comparator: Medtronic IN.PACT Admiral DCB; Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.	Device: Medtronic IN.PACT Admiral DCB; Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants With Device Success	Defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below rated burst pressure, and achievement of <50% residual stenosis of the target lesion (by core lab-assessed quantitative angiography [QA]) without flow-limiting arterial dissection (≥ 50% residual stenosis or dissection grade E or F) using only the study device.	Day 0
Proportion of Participants With Technical Success	Defined as achievement of a final residual diameter stenosis of <50% (by core lab-assessed QA) without flow-limiting arterial dissection at the end of the procedure.	Day 0
Proportion of Participants With Procedure Success	Defined as evidence of both acute technical success and absence of Peripheral Academic Research Consortium major adverse events (PARC MAEs; e.g., death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and or need for urgent/emergent vascular surgery) within 72 hours of the index procedure.	72 hours
Freedom From All-cause Death, Major Target Limb Amputation and TVR Through 30 Days	Proportion of participation free of all-cause death, major target limb amputation and TVR through 30 days. All clinical endpoints adjudications by independent, blinded CEC.	30 days
Proportion of Participants With Primary Lesion Patency	Primary patency through 24 months (only if both the primary safety and efficacy hypotheses of noninferiority are met).	24 months
Proportion of Participants With Target Vessel Patency	Defined as freedom from clinically-driven target vessel revascularization (TVR) and binary restenosis (restenosis defined as DUS PSVR ≥2.4 or ≥50% stenosis as assessed by independent angiographic and DUS core labs) within 12 and 24 months.	12 months, 24 months
Proportion of Participants With Sustained Clinical Improvement	Defined as freedom from major target limb amputation, TVR and worsening target limb Rutherford class, within 6, 12, and 24 months.	6 months, 12 months, 24 months
Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR)	Includes participants experiencing a clinically-driven target lesion revascularization event as reported by sites and adjudicated by an independent CEC.	6 months, 12 months, 24 months
Proportion of Participants With a Historical Major Adverse Events (MAEs)	MAEs defined as composite of all-cause death, clinically-driven TLR, major target limb amputation, or thrombosis at the target lesion, within 6, 12, 24 months.	6 months, 12 months, 24 months
Proportion of Participants With a Major Target Limb Amputation	Major target limb amputation within 6, 12, 24 months as reported by site and adjudicated by CEC.	6 months, 12 months, 24 months
Proportion of Participants With a Thrombosis at the Target Lesion.	Thrombosis at target lesion within 6, 12, 24 months as reported by the site and adjudicated by the CEC.	6 months, 12 months, 24 months
Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI)	Decrease in target limb resting ABI or TBI ≥0.15 from baseline to 6, 12, and 24 months. Ankle-brachial index (ABI) is the ratio of the systolic blood pressure (SBP) measured at the ankle to that measured at the brachial artery. Toe brachial index (TBI) is the ratio of SBP measured at the toe to that measured at the brachial artery. if ABI could not be assessed, TBI could be used.	Screening, 6 months, 12 months, and 24 months
Change in Walking Impairment Questionnaire (WIQ)	Walking Impairment Questionnaire is a validated tool that has 4 domains (Walking Impairment, Walking Distance, Walking Speed, and Stair Climbing), each scored as a percent ranging from 0 (representing the inability to perform any of the tasks) to 100 (representing no difficulty with any of the tasks). A positive change in a score indicates an improvement.	Screening, 1 month, 12 months, and 24 months
Change in 6-Minute Walk Test (6MWT)	Change in 6MWT from baseline to 12 and 24 months.	Screening, 12 months, and 24 months
Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR)	Includes participants experiencing a clinically-driven target lesion revascularization event as reported by sites and adjudicated by an independent CEC.	36 months, 48 months, 60 months
Proportion of Participants With a Historical Major Adverse Events (MAEs)	MAEs defined as composite of all-cause death, clinically-driven TLR, major target limb amputation, or thrombosis at the target lesion within 36, 48, and 60 months.	36 months, 48 months, 60 months
Proportion of Participants With a Major Target Limb Amputation	Major target limb amputation within 36, 48, and 60 months as reported by site and adjudicated by CEC.	36 months, 48 months, 60 months
Change in Target Limb Rutherford Class	Change in target limb Rutherford class from Baseline (BL) to 1, 6, 12, and 24 months. Rutherford classification criteria categorize the severity of chronic limb ischemia based on a clinical description of symptoms and pre-defined objective criteria. Possible scores range from 0 to 6 (with lower scores representing a better outcome) with scores defined as follows: 0 - Asymptomatic - no hemodynamically significant occlusive disease; - Mild claudication; - Moderate claudication; - Severe claudication; - Ischemic rest pain; - Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia; - Major tissue loss, extending above transmetatarsal) with all scores defined as follows: Change = 1-Month scores - BL scores; 6-Month scores - BL scores; 12-Month scores - BL scores; 24-Month scores - BL scores	Baseline, 1 month, 6 months, 12 months, and 24 months
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class	Change in target limb PARC class from baseline to 1, 6, 12, and 24 months. PARC definitions of clinical symptom classification were used to classify subject claudication at baseline and subsequent follow-up visits. PARC clinical symptom classification is used to capture information regarding lower extremity symptoms and broadly define functional limitations of patients with lower extremity peripheral artery disease (PAD). Possible classifications (asymptomatic=best outcome to ischemic gangrene=worst outcome) include the following: Asymptomatic Mild claudication/limb symptoms (no limitation in walking) Moderate claudication/limb symptoms (able to walk without stopping > 2 blocks or 200 meters or 4 minutes) Severe claudication/limb symptoms (only able to walk without stopping < 2 blocks or 200 meters or 4 minutes) Ischemic rest pain (pain in the distal limb at rest, felt to be due to limited arterial perfusion) Ischemic ulcers on distal leg Ischemic gangrene Change =	Screening, 1 month, 6 months, 12 months, and 24 months
Change in Peripheral Artery Questionnaire (PAQ)	The PAQ consists of 7 domains including physical function, stability, symptom, treatment satisfaction, quality of life, social limitation, and summary. Scores range from 0 to 100, with a positive change indicating an improvement. Questionnaire responses include: Extremely Limited, Quite a bit Limited, Moderately Limited, Slightly Limited, Not at all Limited, Limited for other reasons or did not do the activity.	Screening, 1 month, 12 months, and 24 months
Proportion of Participants With a Thrombosis at the Target Lesion	Thrombosis at target lesions within 36, 48, and 60 months as reported by the site and adjudicated by the CEC.	36 months, 48 months, 60 months

Collaborators and Investigators

• Sponsor: SurModics, Inc.
• Investigators: Principal Investigator: William Gray, MD, Lankenau Heart Group; Principal Investigator: Marianne Brodmann, MD, Medical University Graz, Department of Internal Medicine; Principal Investigator: Kenneth Rosenfield, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: J Am Coll Cardiol. 2015 Jun 16;65(23):2578-9.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2017
• Primary Completion (Actual): September 15, 2020
• Study Completion (Actual): September 17, 2024

Study Registration Dates

• First Submitted: August 1, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (Actual): August 7, 2017

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 21, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: PAD; Percutaneous Transluminal Angioplasty; Peripheral Artery Disease; Paclitaxel; PTA
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: SUR17-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes