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Peripheral Arterial DiseaseTRANSCENDNCT03241459

Safety and Efficacy of the SurVeil™ Drug-Coated Balloon

A study testing Surmodics SurVeil DCB and Medtronic IN.PACT Admiral DCB in people with Peripheral Arterial Disease and Peripheral Vascular Disease, run by SurModics, Inc. at 63 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Surmodics SurVeil DCB and Medtronic IN.PACT Admiral DCB
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
446 participants
Where
63 sitesin 9 countries
Study dates
23 Oct 2017to 17 Sep 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 14Show fewer
  • 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.

Who cannot join

  • 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.
Show all 32Show fewer
  • 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.

Trial locations and contacts

63 sites in 9 countries.

63 sites in 9 countries

United States50 sites

  • Mission Hospital

    Asheville, North Carolina, 28801

  • Piedmont Heart Insitute

    Atlanta, Georgia, 30309

  • Emory University Hospital (Clifton)

    Atlanta, Georgia, 30322

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

    Austin, Texas, 78756

  • Cardiovascular Associates of the Southeast

    Birmingham, Alabama, 35243

  • Endovascular Technologies, LLC

    Bossier City, Louisiana, 71111

  • St. Elizabeth's Medical Center

    Boston, Massachusetts, 02135

  • Beth Israel Deaconess

    Boston, Massachusetts, 02215

  • Capital Area Research

    Camp Hill, Pennsylvania, 17011

  • Virtua Medical Group, P.A.

    Cherry Hill, New Jersey, 08034

  • The Lindner Clinical Trial Center

    Cincinnati, Ohio, 45219

  • Clearwater Cardiovascular Consultants

    Clearwater, Florida, 33756

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Ohio Health Research Institute

    Columbus, Ohio, 43214

  • Cardiovascular Associates Research

    Covington, Louisiana, 70433

  • Alexian Brothers Medical Center

    Elk Grove Village, Illinois, 60007

  • North Ohio Heart Center

    Elyria, Ohio, 44035

  • Cardiology Associates

    Foley, Alabama, 36535

  • Mission Cardiovascular Research Institute

    Fremont, California, 94538

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Dignity Health

    Gilbert, Arizona, 85297

  • Moses Cone-LeBauer

    Greensboro, North Carolina, 27401

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Houston Cardiovascular Association

    Houston, Texas, 77030

  • St Vincent Heart (Research Department)

    Indianapolis, Indiana, 46290

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Ballad Health System

    Kingsport, Tennessee, 37660

  • Turkey Creek Medical Center

    Knoxville, Tennessee, 37934

  • North Dallas Research Associates

    McKinney, Texas, 75069

  • Advocate Health

    Naperville, Illinois, 60540

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510

  • Columbia University Medical Center/NYPH

    New York, New York, 10032

  • St. Michael's Hospital

    Newark, New Jersey, 07102

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

    Ocala, Florida, 34478

  • Oklahoma Cardiovascular Research Group

    Oklahoma City, Oklahoma, 73120

  • University of Nebraska

    Omaha, Nebraska, 68198

  • Northern Michigan Hospital

    Petoskey, Michigan, 49770

  • Bryn Mawr Hospital - Main Line Health System (Einstein)

    Philadelphia, Pennsylvania, 19141

  • Providence Heart and Vascular

    Portland, Oregon, 97225

  • The Miriam Hospital

    Providence, Rhode Island, 02906

  • North Carolina Heart and Vascular

    Raleigh, North Carolina, 27607

  • North Memorial Hospital

    Robbinsdale, Minnesota, 55422

  • Prairie Education (PERC)

    Springfield, Illinois, 62701

  • Mercy Hospital

    Springfield, Missouri, 65804

  • Holy Name Medical Center

    Teaneck, New Jersey, 07666

  • University of Toledo Medical Center

    Toledo, Ohio, 43614

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Iowa Heart Center

    West Des Moines, Iowa, 50266

  • Pinnacle Health Cardiovascular Institute

    Wormleysburg, Pennsylvania, 17043

  • Yuma Regional Medical Center

    Yuma, Arizona, 85364

Other trials in United States

Germany4 sites

  • Herz Zentrum Bad Krozingen Südring

    Bad Krozingen

  • SRH Klinikum KarlsbadLangensteinbach

    Karlsbad

  • Universitätsklinikum Leipzig

    Leipzig

  • REGIOMED-KLINIKEN GmbH

    Sonneberg

Other trials in Germany

Belgium2 sites

  • AZ Sint Blasius

    Dendermonde

  • UZ GENT

    Ghent

Other trials in Belgium

Czechia2 sites

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

    Brno

  • Vitkovicka Nemocnice Ostrava Vítkovická nemocnice, a.s.,

    Ostrava

Other trials in Czechia

Australia1 site

  • Prince of Wales Private Hostpital

    Randwick

Other trials in Australia

Austria1 site

  • Institution Medizinische Universitat

    Graz

Other trials in Austria

Italy1 site

  • Aou Careggi University Hospital

    Florence

Other trials in Italy

Latvia1 site

  • Pauls Stradins Clinical University Hospital

    Riga

Other trials in Latvia

New Zealand1 site

  • Auckland City Hospital

    Auckland

Other trials in New Zealand

About this study

Official title: 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.

Read the 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.

Being tested
Surmodics SurVeil DCB, Medtronic IN.PACT Admiral DCB
Keywords
Percutaneous Transluminal Angioplasty, PTA, Peripheral Artery Disease, PAD, Paclitaxel
Medical subject headings
Peripheral Arterial Disease, Peripheral Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Surmodics SurVeil DCBDevice

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

  • Medtronic IN.PACT Admiral DCBDevice

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

Study groups in NCT03241459
Study groupRoleWhat they receive
Surmodics SurVeil DCBExperimentalSurmodics SurVeil Drug-Coated Balloon is an investigational device coated with paclitaxel.
Receives: Device: Surmodics SurVeil DCB
Medtronic IN.PACT Admiral DCBActive comparatorAngioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
Receives: Device: Medtronic IN.PACT Admiral DCB

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. 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.

    Measured: 12 months

Secondary outcomes (21)

  1. 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.

    Measured: Day 0

  2. 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.

    Measured: Day 0

  3. 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.

    Measured: 72 hours

  4. 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.

    Measured: 30 days

  5. 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).

    Measured: 24 months

  6. 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.

    Measured: 12 months, 24 months

  7. 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.

    Measured: 6 months, 12 months, 24 months

  8. 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.

    Measured: 6 months, 12 months, 24 months

  9. 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.

    Measured: 6 months, 12 months, 24 months

  10. 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.

    Measured: 6 months, 12 months, 24 months

  11. 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.

    Measured: 6 months, 12 months, 24 months

  12. 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

    1. - Mild claudication
    2. - Moderate claudication
    3. - Severe claudication
    4. - Ischemic rest pain
    5. - Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia
    6. - 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

    Measured: Baseline, 1 month, 6 months, 12 months, and 24 months

  13. 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 =

    Measured: Screening, 1 month, 6 months, 12 months, and 24 months

  14. 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.

    Measured: Screening, 6 months, 12 months, and 24 months

  15. 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.

    Measured: Screening, 1 month, 12 months, and 24 months

  16. Change in 6-Minute Walk Test (6MWT)

    Change in 6MWT from baseline to 12 and 24 months.

    Measured: Screening, 12 months, and 24 months

  17. 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.

    Measured: Screening, 1 month, 12 months, and 24 months

  18. 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.

    Measured: 36 months, 48 months, 60 months

  19. 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.

    Measured: 36 months, 48 months, 60 months

  20. 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.

    Measured: 36 months, 48 months, 60 months

  21. 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.

    Measured: 36 months, 48 months, 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2017
  2. Study start23 Oct 2017
  3. Primary completion15 Sep 2020
  4. Study completion17 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
446 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03241459
Sponsor's protocol ID
SUR17-001
Acronym
TRANSCEND
Status last verified
Mar 2025
First submitted
1 Aug 2017
Last updated
25 Mar 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

    PubMed 16549646

  • 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.

    PubMed 17140820

  • 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.

    PubMed 26476467

  • 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.

    PubMed 26106946

  • 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.

    PubMed 25744011

  • 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.

    PubMed 39615582

  • 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.

    PubMed 30685679

Questions about this trial

What is this clinical trial studying?

A study testing Surmodics SurVeil DCB and Medtronic IN.PACT Admiral DCB in people with Peripheral Arterial Disease and Peripheral Vascular Disease, run by SurModics, Inc. at 63 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in United States, Germany, Belgium, Czechia, Australia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Lesion Patency Though 12 Months (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03241459, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.

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