Safety and Efficacy of the SurVeil™ Drug-Coated Balloon

Not Applicable

Completed

Conditions: Peripheral Vascular Disease
Femoropopliteal Artery Occlusion
Artery Disease, Peripheral
Peripheral Arterial Disease

Registration Number: NCT03241459

Lead Sponsor: SurModics, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 446

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary Lesion Patency Though 12 Months	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.
Safety Composite of Freedom From Death, Amputation, and Target Vessel Revascularization (TVR)	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

Name	Time	Method
Proportion of Participants With Device Success	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 (≥ 50% residual stenosis or dissection grade E or F) using only the study device.
Proportion of Participants With Technical Success	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.
Proportion of Participants With Procedure Success	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.
Freedom From All-cause Death, Major Target Limb Amputation and TVR Through 30 Days	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.
Proportion of Participants With Primary Lesion Patency	24 months	Primary patency through 24 months (only if both the primary safety and efficacy hypotheses of noninferiority are met).
Proportion of Participants With Target Vessel Patency	12 months, 24 months	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.
Proportion of Participants With Sustained Clinical Improvement	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.
Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR)	36 months, 48 months, 60 months	Includes participants experiencing a clinically-driven target lesion revascularization event as reported by sites and adjudicated by an independent CEC.
Proportion of Participants With a Historical Major Adverse Events (MAEs)	36 months, 48 months, 60 months	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.
Proportion of Participants With a Major Target Limb Amputation	36 months, 48 months, 60 months	Major target limb amputation within 36, 48, and 60 months as reported by site and adjudicated by CEC.
Proportion of Participants With a Thrombosis at the Target Lesion.	6 months, 12 months, 24 months	Thrombosis at target lesion within 6, 12, 24 months as reported by the site and adjudicated by the CEC.
Change in Target Limb Rutherford Class	Baseline, 1 month, 6 months, 12 months, and 24 months	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
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class	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. 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 =
Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI)	Screening, 6 months, 12 months, and 24 months	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.
Change in Walking Impairment Questionnaire (WIQ)	Screening, 1 month, 12 months, and 24 months	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.
Change in 6-Minute Walk Test (6MWT)	Screening, 12 months, and 24 months	Change in 6MWT from baseline to 12 and 24 months.
Change in Peripheral Artery Questionnaire (PAQ)	Screening, 1 month, 12 months, and 24 months	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.
Proportion of Participants With a Thrombosis at the Target Lesion	36 months, 48 months, 60 months	Thrombosis at target lesions within 36, 48, and 60 months as reported by the site and adjudicated by the CEC.

Trial Locations

Locations (63): Cardiovascular Associates of the Southeast
🇺🇸
Birmingham, Alabama, United States
Cardiology Associates
🇺🇸
Foley, Alabama, United States
Dignity Health
🇺🇸
Gilbert, Arizona, United States
Yuma Regional Medical Center
🇺🇸
Yuma, Arizona, United States
Mission Cardiovascular Research Institute
🇺🇸
Fremont, California, United States
Yale New Haven Hospital
🇺🇸
New Haven, Connecticut, United States
MedStar Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Clearwater Cardiovascular Consultants
🇺🇸
Clearwater, Florida, United States
Advent Health Ocala/MediQuest Research Group LLC (formerly FL Hospital /Munroe)
🇺🇸
Ocala, Florida, United States
Piedmont Heart Insitute
🇺🇸
Atlanta, Georgia, United States
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Cardiovascular Associates of the Southeast
🇺🇸Birmingham, Alabama, United States