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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04107298

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Safety and Feasibility of Surmodics SUNDANCE™ Drug Coated Balloon
Scientific title
A Prospective, Multi-Center, Single-Arm, Feasibility Study to Assess the Safety and Performance WIth the SUNDANCE™ DruG Coated Balloon for the Treatment of De Novo or Restenotic Lesions in Infra-Popliteal Arteries
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peripheral Arterial Disease 0 0
Critical Lower Limb Ischemia 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Study type
Description of intervention(s) / exposure
Treatment: Devices - SUNDANCE™ Drug Coated Balloon

Experimental: SUNDANCE™ Drug Coated Balloon - SUNDANCE™ Drug Coated Balloon

Treatment: Devices: SUNDANCE™ Drug Coated Balloon
Angioplasty procedure with a sirolimus-coated, percutaneous transluminal angioplasty (PTA) balloon catheter

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Primary Safety Endpoint: Number of Participants with a composite of freedom from Major Adverse Limb Event (MALE) and perioperative death - MALE is defined as the composite of either major amputation or major re-intervention through 30 days of the index procedure. Major amputation is defined as limb amputation above the ankle. Major re-intervention is defined as the creation of new surgical bypass graft, the use of thrombectomy or thrombolysis, or major surgical graft revision such as a jump graft or an interposition graft.
Timepoint [1] 0 0
30 Days
Primary outcome [2] 0 0
Primary Efficacy Endpoint: Rate of Late Lumen Loss (LLL) - LLL is assessed by quantitative vascular angiography (QVA). LLL is the difference between minimum lumen diameter (MLD) immediately after PTA and MLD at 6 months follow-up.
Timepoint [2] 0 0
6 Months
Secondary outcome [1] 0 0
Rate of Device Success - Successful delivery, balloon inflation, deflation and retrieval of the intact study device
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Rate of Technical Success - Successful vascular access, completion of endovascular procedure and immediate achievement of = 50% residual stenosis (by core lab-assessed quantitative vascular angiography) of the treated lesion on completion of angiography.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Rate of Procedure Success - Device Success or Technical Success and the absence of procedural complications.
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Rate of Restenosis - Assessed by Transverse-view vessel area loss percentage (TVAL%) assessed by QVA. TVAL% of the target lesion at 6 months or prior to any clinically driven target lesion revascularization (CD-TLR) of the target lesion prior to 6 months.
Timepoint [4] 0 0
6 Months or prior
Secondary outcome [5] 0 0
Number of Participants with Primary Patency - Freedom from target vessel occlusion as determined by DUS and CD-TLR. CD-TLR is defined as any TLR of the target lesion associated with deterioration of Rutherford Class and/or increase in size of pre-existing wounds and/or occurrence of new wound(s), and lesion restenosis >50% determined by angiography.
Timepoint [5] 0 0
30 Days, 6 Months, 12 Months, 24 Months
Secondary outcome [6] 0 0
Major Adverse Event (MAE) rate - Composite rate of all-cause death, target limb major amputation and CD-TLR.
Timepoint [6] 0 0
30 Days, 6 Months, 12 Months, 24 Months
Secondary outcome [7] 0 0
Amputation Free Survival - Rate of subjects not requiring major amputations
Timepoint [7] 0 0
6 Months, 12 Months, 24 Months
Secondary outcome [8] 0 0
Hemodynamic outcomes - Change in ankle brachial index (ABI) and toe pressure from pre-procedure.
Timepoint [8] 0 0
30 Days, 6 Months, 12 Months, 24 Months
Secondary outcome [9] 0 0
Change in Rutherford-Becker Classification - Change from pre-procedure
Timepoint [9] 0 0
30 Days, 6 Months, 12 Months, 24 Months
Secondary outcome [10] 0 0
EQ-5D - The EQ-5D is not an abbreviation. It is a quality of Life evaluation quantified as the change from pre-procedure to time points specified below. The descriptive system comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Each level corresponds to 1-digit number expressing the level selected for that dimension.
The EQ VAS corresponds to a 20 cm vertical, visual analogue scale raging from 'the best health you can imagine' to 'the worst health you can imagine'
Timepoint [10] 0 0
30 Days, 6 Months, 12 Months, 24 Months
Secondary outcome [11] 0 0
Walking Impairment Questionnaire (WIQ) - Walking Capacity Assessment quantified as the change from pre-procedure to time points specified below.The questions characterize patients' self-reported degree of difficulty in walking a defined distance (5, 3, 2, 1, 1/2 city blocks, 50 ft. or around the home) and speed (running/jogging one block, walking one block quickly, walking one block at average speed, or walking one block slowly). These responses are ranked on a scale of 0 to 4, (0=unable to do, 4=no difficulty). Subscale scores are determined by dividing the weighted answers by the maximum possible weighted score and multiplying by 100. Each score ranges from 0-100 with lower scores indicating lower performance. The overall score is the average of all 3 subscores.
Timepoint [11] 0 0
30 Days, 6 Months, 12 Months, 24 Months
Secondary outcome [12] 0 0
Vascular Quality of Life Questionnaire (VascuQol) - Quality of Life evaluation quantified as the change from pre-procedure to time points specified below. VascuQol is an instrument in which the participant is asked about their concerns, abilities, and activities. Overall values can range from 6 to 24, with a higher total sum representing better participant health.
Timepoint [12] 0 0
30 Days, 6 Months, 12 Months, 24 Months

Key inclusion criteria
Clinical Inclusion Criteria

- Subject is =18 years.

- Subject has target limb Rutherford classification 4 or 5. Rutherford classification 3
subjects may be enrolled but will be capped to a limit of 20% of the total enrollment
(i.e., no more than 7 Rutherford class 3 subjects may be enrolled in the study).

- Subject has provided written informed consent and is willing to comply with study
follow-up requirements.

Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Exclusion Criteria

- Subject has acute limb ischemia.

- Subject underwent intervention involving the target vessel (not a proximal inflow
vessel) within the previous 90 days.

- Subject previously underwent PTA of the target lesion vessel using a DCB or DES.

- 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.

- Subjects with heel gangrene, deep heel ulcers, osteomyelitis of tarsal or metatarsal
bones (which extends beyond the metatarsal head immediately adjacent to the
metatarso-phalangeal joint), and subjects with exposed vital structures (e.g., medial
or lateral malleolus).

- Subjects requiring pedal angioplasty.

- Subjects that are non-ambulatory and confined to bed.

- Women who are pregnant, breast-feeding or intend to become pregnant or men who intend
to father children during the time of the study.

- Subject has history of Class 3 (and above) congestive heart failure (CHF) in past 6

- Subject has life expectancy less than 12 months.

- Subject has a known allergy to contrast medium that cannot be adequately

- Subject has known hypersensitivity to sirolimus

- Subject has a known contraindication to the intended concomitant medications.

- Subject is allergic to ALL antiplatelet treatments.

- Subject has impaired renal function (i.e. serum creatinine level =2.5 mg/dL or =221

- Subject had major limb amputation on the affected side in last year or has planned
major limb amputation.

- 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 or other disorders which are contraindications
for treatment with systemic anticoagulation and/or dual antiplatelet therapy (DAPT).

- Subject has history of stroke within the past 3 months.

- 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

- 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

- Subject had previous bypass surgery of the target lesion.

- Subject had previously implanted stent in 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

Angiographic Inclusion Criteria

- The target lesion/vessel must meet all of the following angiographic criteria for the
subject to participate in the trial:

- De novo lesion(s) or non-stented restenotic lesion

- Target lesion location starts at the P3 segment and terminates at 1cm above the ankle.
Note: Isolated P3 lesion is not allowed. If a lesion starts in the P3 segment, it must
continue into the infrapopliteal.

- Target vessel diameter =2 mm and =4 mm, based on visual estimation.

- Target lesion must have angiographic evidence of =70% stenosis by operator visual

- Chronic total occlusions may be included only after successful, uncomplicated 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. Use of re-entry/crossing devices
is not allowed. Crossing may be performed retrograde, but treatment must be performed

Uncomplicated: Upon visual inspection, no occurrence of embolization, perforation, or
occurrence of flow-limiting dissection.

- Target lesion(s) must be =230 mm in total lesion(s) length by operator visual
estimate. A maximum of two lesions may be treated. The two lesions may be in one
infrapopliteal vessel or in two distinct infrapopliteal vessels. Note: Tandem lesions
may be considered a single lesion if they are separated by =30 mm.

- After pre-dilatation, the target lesion has =70% residual stenosis, absence of a flow
limiting dissection (Grade D or greater) and treatable with available device matrix.

- A patent inflow artery free from significant stenosis (=50% stenosis) as confirmed by

- At least one patent native outflow artery to the ankle or foot distal to the lesion
being treated, free from significant stenosis (=50% stenosis) as confirmed by

Angiographic Exclusion Criteria

- Aneurysm in the target vessel or proximal inflow artery.

- Inflow lesion or occlusion in the ipsilateral Iliac, SFA, popliteal arteries with
length =15 cm.

- Significant stenosis (= 50%) in inflow lesion or occlusion in the ipsilateral iliac,
SFA, popliteal arteries left untreated.

- Target lesion requires treatment with alternative therapy such as stenting, laser,
atherectomy, cryoplasty, brachytherapy, or re-entry devices.

- Significant target vessel tortuosity or other parameters prohibiting access to the
target lesion.

- Presence of thrombus in the target vessel.

Study design
Purpose of the study
Allocation to intervention
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
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Single group
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Prince of Wales Private Hospital - Randwick
Recruitment postcode(s) [1] 0 0
- Randwick
Recruitment outside Australia
Country [1] 0 0
State/province [1] 0 0
Country [2] 0 0
State/province [2] 0 0
Country [3] 0 0
New Zealand
State/province [3] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
SurModics, Inc.

Ethics approval
Ethics application status

Brief summary
To evaluate the safety and performance of the Sundance™ DCB in subjects with occlusive
disease of the infrapopliteal arteries.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amy Froberg, CCRP
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04107298