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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03241459




Registration number
NCT03241459
Ethics application status
Date submitted
1/08/2017
Date registered
7/08/2017

Titles & IDs
Public title
Safety and Efficacy of the SurVeil™ Drug-Coated Balloon
Scientific 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
Secondary ID [1] 0 0
SUR17-001
Universal Trial Number (UTN)
Trial acronym
TRANSCEND
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 0 0
Peripheral Vascular Disease 0 0
Artery Disease, Peripheral 0 0
Femoropopliteal Artery Occlusion 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Surmodics SurVeil DCB
Treatment: Devices - Medtronic IN.PACT Admiral DCB

Experimental: Surmodics SurVeil DCB - Surmodics SurVeil Drug-Coated Balloon is an investigational device coated with paclitaxel.

Active comparator: Medtronic IN.PACT Admiral DCB - Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.


Treatment: Devices: Surmodics SurVeil DCB
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.

Treatment: Devices: Medtronic IN.PACT Admiral DCB
Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Lesion Patency Though 12 Months
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Safety Composite of Freedom From Death, Amputation, and Target Vessel Revascularization (TVR)
Timepoint [2] 0 0
12 months
Secondary outcome [1] 0 0
Proportion of Participants With Device Success
Timepoint [1] 0 0
Day 0
Secondary outcome [2] 0 0
Proportion of Participants With Technical Success
Timepoint [2] 0 0
Day 0
Secondary outcome [3] 0 0
Proportion of Participants With Procedure Success
Timepoint [3] 0 0
72 hours
Secondary outcome [4] 0 0
Freedom From All-cause Death, Major Target Limb Amputation and TVR Through 30 Days
Timepoint [4] 0 0
30 days
Secondary outcome [5] 0 0
Proportion of Participants With Primary Lesion Patency
Timepoint [5] 0 0
24 months
Secondary outcome [6] 0 0
Proportion of Participants With Target Vessel Patency
Timepoint [6] 0 0
12 months, 24 months
Secondary outcome [7] 0 0
Proportion of Participants With Sustained Clinical Improvement
Timepoint [7] 0 0
6 months, 12 months, 24 months
Secondary outcome [8] 0 0
Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR)
Timepoint [8] 0 0
6 months, 12 months, 24 months
Secondary outcome [9] 0 0
Proportion of Participants With a Historical Major Adverse Events (MAEs)
Timepoint [9] 0 0
6 months, 12 months, 24 months
Secondary outcome [10] 0 0
Proportion of Participants With a Major Target Limb Amputation
Timepoint [10] 0 0
6 months, 12 months, 24 months
Secondary outcome [11] 0 0
Proportion of Participants With a Thrombosis at the Target Lesion.
Timepoint [11] 0 0
6 months, 12 months, 24 months
Secondary outcome [12] 0 0
Change in Target Limb Rutherford Class
Timepoint [12] 0 0
Baseline, 1 month, 6 months, 12 months, and 24 months
Secondary outcome [13] 0 0
Change in Target Limb Peripheral Academic Research Consortium (PARC) Class
Timepoint [13] 0 0
Screening, 1 month, 6 months, 12 months, and 24 months
Secondary outcome [14] 0 0
Decrease in Target Limb Resting Ankle Brachial Index (ABI) or Toe Brachial Index (TBI)
Timepoint [14] 0 0
Screening, 6 months, 12 months, and 24 months
Secondary outcome [15] 0 0
Change in Walking Impairment Questionnaire (WIQ)
Timepoint [15] 0 0
Screening, 1 month, 12 months, and 24 months
Secondary outcome [16] 0 0
Change in 6-Minute Walk Test (6MWT)
Timepoint [16] 0 0
Screening, 12 months, and 24 months
Secondary outcome [17] 0 0
Change in Peripheral Artery Questionnaire (PAQ)
Timepoint [17] 0 0
Screening, 1 month, 12 months, and 24 months
Secondary outcome [18] 0 0
Proportion of Participants With a Clinically-Driven Target Lesion Revascularization (TLR)
Timepoint [18] 0 0
36 months, 48 months, 60 months
Secondary outcome [19] 0 0
Proportion of Participants With a Historical Major Adverse Events (MAEs)
Timepoint [19] 0 0
36 months, 48 months, 60 months
Secondary outcome [20] 0 0
Proportion of Participants With a Major Target Limb Amputation
Timepoint [20] 0 0
36 months, 48 months, 60 months
Secondary outcome [21] 0 0
Proportion of Participants With a Thrombosis at the Target Lesion
Timepoint [21] 0 0
36months, 48 months, 60 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
23/10/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2024
Actual
Sample size
Target
Accrual to date
Final
446
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Prince of Wales Private Hostpital - Randwick
Recruitment postcode(s) [1] 0 0
- Randwick
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Kansas
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Minnesota
Country [16] 0 0
United States of America
State/province [16] 0 0
Mississippi
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
Nebraska
Country [19] 0 0
United States of America
State/province [19] 0 0
New Jersey
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Ohio
Country [23] 0 0
United States of America
State/province [23] 0 0
Oklahoma
Country [24] 0 0
United States of America
State/province [24] 0 0
Oregon
Country [25] 0 0
United States of America
State/province [25] 0 0
Pennsylvania
Country [26] 0 0
United States of America
State/province [26] 0 0
Rhode Island
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
Austria
State/province [29] 0 0
Graz
Country [30] 0 0
Belgium
State/province [30] 0 0
Dendermonde
Country [31] 0 0
Belgium
State/province [31] 0 0
Ghent
Country [32] 0 0
Czechia
State/province [32] 0 0
Brno
Country [33] 0 0
Czechia
State/province [33] 0 0
Ostrava
Country [34] 0 0
Germany
State/province [34] 0 0
Bad Krozingen
Country [35] 0 0
Germany
State/province [35] 0 0
Karlsbad
Country [36] 0 0
Germany
State/province [36] 0 0
Leipzig
Country [37] 0 0
Germany
State/province [37] 0 0
Sonneberg
Country [38] 0 0
Italy
State/province [38] 0 0
Florence
Country [39] 0 0
Latvia
State/province [39] 0 0
Riga
Country [40] 0 0
New Zealand
State/province [40] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
SurModics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
William Gray, MD
Address 0 0
Lankenau Heart Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03241459