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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03241459
Recruitment Status : Active, not recruiting
First Posted : August 7, 2017
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
SurModics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Peripheral Vascular Disease Artery Disease, Peripheral Femoropopliteal Artery Occlusion Device: Surmodics SurVeil DCB Device: Medtronic IN.PACT Admiral DCB Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 446 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Randomized And Controlled Noninferiority Trial to Evaluate Safety and Clinical Efficacy of the SurVeil™ Drug-Coated Balloon iN the Treatment of Subjects With Stenotic Lesions of the Femoropopliteal Artery Compared to the Medtronic IN.PACT® Admiral® Drug-Coated Balloon
Actual Study Start Date : October 23, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2024
Arms and Interventions
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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. Study is 1:1 randomized against comparator.
Active Comparator: Medtronic IN.PACT Admiral DCB Device: Medtronic IN.PACT Admiral DCB
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter. Study is 1:1 randomized against SurVeil DCB.


Outcome Measures
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Primary Outcome Measures :
  1. Primary Lesion Patency [ Time Frame: 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.

  2. Safety composite of death, amputation, and target vessel revascularization (TVR) [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Device Success [ Time Frame: Day 0 ]
    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 using only the study device.

  2. Technical Success [ Time Frame: Day 0 ]
    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.

  3. Procedure Success [ Time Frame: 72 hours ]
    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.

  4. Clinical Success [ Time Frame: 30 days ]
    Freedom from all-cause death, major target limb amputation and TVR through 30 days

  5. Primary Lesion Patency [ Time Frame: 24 months ]

    Applicable only if both the primary safety and efficacy hypotheses of noninferiority are met.

    Primary patency defined as a 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).


  6. Target Vessel Patency [ Time Frame: 12 months, 24 months ]
    Defined as freedom from clinically-driven TVR and binary restenosis (restenosis defined as DUS PSVR ≥2.4 or ≥50% stenosis as assessed by independent angiographic and DUS core labs).

  7. Sustained Clinical Improvement [ Time Frame: 6 months, 12 months, 24 months ]
    Defined as freedom from major target limb amputation, TVR and worsening target limb Rutherford class, within 6, 12, and 24 months.

  8. Clinically-driven TLR [ Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months ]
    Clinically-driven target lesion revascularization, within 6, 12, 24, 36, 48, and 60 months

  9. Historical MAEs [ Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months ]
    Major Adverse Events (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, 36, 48, and 60 months.

  10. Major amputation [ Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months ]
    Major target limb amputation, within 6, 12, 24, 36, 48, and 60 months.

  11. Thrombosis [ Time Frame: 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months ]
    Thrombosis at target limb, within 6, 12, 24, 36, 48, and 60 months.

  12. Rutherford Class [ Time Frame: Screening, 1 month, 6 months, 12 months, and 24 months ]
    Change in target limb Rutherford class from baseline to 1, 6, 12, and 24 months.

  13. PARC Class [ Time Frame: Screening, 1 month, 6 months, 12 months, and 24 months ]
    Change in target limb PARC class from baseline to 1, 6, 12, and 24 months.

  14. Ankle Brachial Index (ABI) [ Time Frame: Screening, 6 months, 12 months, and 24 months ]
    Decrease in target limb ABI or toe brachial index ≥0.15 from baseline to 6, 12, and 24 months.

  15. Walking Impairment Questionnaire (WIQ) [ Time Frame: Screening, 1 month, 12 months, and 24 months ]
    Change in WIQ score from baseline to 1, 12, and 24 months.

  16. Six Minute Walk Test (6MWT) [ Time Frame: Screening, 12 months, and 24 months ]
    Change in 6MWT from baseline to 12 and 24 months.

  17. Peripheral Artery Questionnaire (PAQ) [ Time Frame: Screening, 1 month, 12 months, and 24 months ]
    Change in PAQ score from baseline to 1, 12, and 24 months.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241459


Locations
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Sponsors and Collaborators
SurModics, Inc.
Investigators
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Principal Investigator: 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
More Information
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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. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: SurModics, Inc.
ClinicalTrials.gov Identifier: NCT03241459    
Other Study ID Numbers: SUR17-001
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by SurModics, Inc.:
Percutaneous Transluminal Angioplasty
PTA
Peripheral Artery Disease
PAD
Paclitaxel
Additional relevant MeSH terms:
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Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Cardiovascular Diseases
 Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases