Clinical trial NCT03241459: Safety and Efficacy of the SurVeil™ Drug-Coated Balloon
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Peripheral Vascular Disease
Artery Disease, Peripheral
Femoropopliteal Artery Occlusion
Keywords: Percutaneous Transluminal Angioplasty
PTA
Peripheral Artery Disease
PAD
Paclitaxel
Lead sponsor: SurModics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-08-07
Enrollment: 446
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Primary Lesion Patency Though 12 Months
timeFrame: 12 months
measure: Safety Composite of Freedom From Death, Amputation, and Target Vessel Revascularization (TVR)
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of Participants With Device Success
timeFrame: Day 0
measure: Proportion of Participants With Technical Success
timeFrame: Day 0
measure: Proportion of Participants With Procedure Success
timeFrame: 72 hours
measure: Freedom From All-cause Death, Major Target Limb Amputation and TVR Through 30 Days
timeFrame: 30 days
measure: Proportion of Participants With Primary Lesion Patency
timeFrame: 24 months
measure: Proportion of Participants With Target Vessel Patency
timeFrame: 12 months, 24 months
measure: Proportion of Participants With Sustained Clinical Improvement
timeFrame: 6 months, 12 months, 24 months
measure: Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR)
timeFrame: 6 months, 12 months, 24 months
measure: Proportion of Participants With a Historical Major Adverse Events (MAEs)
timeFrame: 6 months, 12 months, 24 months
measure: Proportion of Participants With a Major Target Limb Amputation
timeFrame: 6 months, 12 months, 24 months
measure: Proportion of Participants With a Thrombosis at the Target Lesion.
timeFrame: 6 months, 12 months, 24 months
measure: Change in Target Limb Rutherford Class
timeFrame: Baseline, 1 month, 6 months, 12 months, and 24 months
measure: Change in Target Limb Peripheral Academic Research Consortium (PARC) Class
timeFrame: Screening, 1 month, 6 months, 12 months, and 24 months
measure: Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI)
timeFrame: Screening, 6 months, 12 months, and 24 months
measure: Change in Walking Impairment Questionnaire (WIQ)
timeFrame: Screening, 1 month, 12 months, and 24 months
measure: Change in 6-Minute Walk Test (6MWT)
timeFrame: Screening, 12 months, and 24 months
measure: Change in Peripheral Artery Questionnaire (PAQ)
timeFrame: Screening, 1 month, 12 months, and 24 months
measure: Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR)
timeFrame: 36 months, 48 months, 60 months
measure: Proportion of Participants With a Historical Major Adverse Events (MAEs)
timeFrame: 36 months, 48 months, 60 months
measure: Proportion of Participants With a Major Target Limb Amputation
timeFrame: 36 months, 48 months, 60 months
measure: Proportion of Participants With a Thrombosis at the Target Lesion
timeFrame: 36 months, 48 months, 60 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cardiovascular Associates of the Southeast
state: Alabama
city: Foley
country: United States
facility: Cardiology Associates
state: Alabama
city: Gilbert
country: United States
facility: Dignity Health
state: Arizona
city: Yuma
country: United States
facility: Yuma Regional Medical Center
state: Arizona
city: Fremont
country: United States
facility: Mission Cardiovascular Research Institute
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Ocala
country: United States
facility: Advent Health Ocala/MediQuest Research Group LLC (formerly FL Hospital /Munroe)
state: Florida
city: Atlanta
country: United States
facility: Piedmont Heart Insitute
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital (Clifton)
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Elk Grove Village
country: United States
facility: Alexian Brothers Medical Center
state: Illinois
city: Naperville
country: United States
facility: Advocate Health
state: Illinois
city: Springfield
country: United States
facility: Prairie Education (PERC)
state: Illinois
city: Indianapolis
country: United States
facility: St Vincent Heart (Research Department)
state: Indiana
city: West Des Moines
country: United States
facility: Iowa Heart Center
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Bossier City
country: United States
facility: Endovascular Technologies, LLC
state: Louisiana
city: Covington
country: United States
facility: Cardiovascular Associates Research
state: Louisiana
city: Boston
country: United States
facility: St. Elizabeth's Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess
state: Massachusetts
city: Petoskey
country: United States
facility: Northern Michigan Hospital
state: Michigan
city: Robbinsdale
country: United States
facility: North Memorial Hospital
state: Minnesota
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Springfield
country: United States
facility: Mercy Hospital
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: Cherry Hill
country: United States
facility: Virtua Medical Group, P.A.
state: New Jersey
city: Newark
country: United States
facility: St. Michael's Hospital
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center/NYPH
state: New York
city: Asheville
country: United States
facility: Mission Hospital
state: North Carolina
city: Greensboro
country: United States
facility: Moses Cone-LeBauer
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Heart and Vascular
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Clinical Trial Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio Health Research Institute
state: Ohio
city: Elyria
country: United States
facility: North Ohio Heart Center
state: Ohio
city: Toledo
country: United States
facility: University of Toledo Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Cardiovascular Research Group
state: Oklahoma
city: Portland
country: United States
facility: Providence Heart and Vascular
state: Oregon
city: Camp Hill
country: United States
facility: Capital Area Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: Bryn Mawr Hospital - Main Line Health System (Einstein)
state: Pennsylvania
city: Wormleysburg
country: United States
facility: Pinnacle Health Cardiovascular Institute
state: Pennsylvania
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
city: Kingsport
country: United States
facility: Ballad Health System
state: Tennessee
city: Knoxville
country: United States
facility: Turkey Creek Medical Center
state: Tennessee
city: Austin
country: United States
facility: St. David's Heart & Vascular PLLC dba Austin Heart
state: Texas
city: Houston
country: United States
facility: Houston Cardiovascular Association
state: Texas
city: McKinney
country: United States
facility: North Dallas Research Associates
state: Texas
city: Randwick
country: Australia
facility: Prince of Wales Private Hostpital
city: Graz
country: Austria
facility: Institution Medizinische Universitat
city: Dendermonde
country: Belgium
facility: AZ Sint Blasius
city: Ghent
country: Belgium
facility: UZ GENT
city: Brno
country: Czechia
facility: FN u sv. Anny v Brně a LF MU (Centrum cévních onemocnění II. chirurgická klinika)
city: Ostrava
country: Czechia
facility: Vitkovicka Nemocnice Ostrava Vítkovická nemocnice, a.s.,
city: Bad Krozingen
country: Germany
facility: Herz Zentrum Bad Krozingen Südring
city: Karlsbad
country: Germany
facility: SRH Klinikum KarlsbadLangensteinbach
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Sonneberg
country: Germany
facility: REGIOMED-KLINIKEN GmbH
city: Florence
country: Italy
facility: Aou Careggi University Hospital
city: Riga
country: Latvia
facility: Pauls Stradins Clinical University Hospital
city: Auckland
country: New Zealand
facility: Auckland City Hospital
Study officials:
affiliation: Lankenau Heart Group
name: William Gray, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Kenneth Rosenfield, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University Graz, Department of Internal Medicine
name: Marianne Brodmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.