Safety and Feasibility of Surmodics SUNDANCE™ Drug Coated Balloon
- Conditions
- Critical Lower Limb IschemiaPeripheral Arterial Disease
- Registration Number
- NCT04107298
- Lead Sponsor
- SurModics, Inc.
- Brief Summary
To evaluate the safety and performance of the Sundance™ DCB in subjects with occlusive disease of the infrapopliteal arteries.
- Detailed Description
SWING is a prospective, multi-center, single-arm, feasibility study to assess the safety and performance of the Sundance™ drug coated balloon for the treatment of de novo or restenotic lesions in infra-popliteal Arteries. Approximately 35 subjects will be treated at up to 8 sites.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Primary Safety Endpoint: Number of Participants with a composite of freedom from Major Adverse Limb Event (MALE) and perioperative death 30 Days 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.
Primary Efficacy Endpoint: Rate of Late Lumen Loss (LLL) 6 Months 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.
- Secondary Outcome Measures
Name Time Method Rate of Technical Success Acute/Periprocedural 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.
Rate of Restenosis 6 Months or prior 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.
Walking Impairment Questionnaire (WIQ) 30 Days, 6 Months, 12 Months, 24 Months 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.
Major Adverse Event (MAE) rate 30 Days, 6 Months, 12 Months, 24 Months Composite rate of all-cause death, target limb major amputation and CD-TLR.
Change in Rutherford-Becker Classification 30 Days, 6 Months, 12 Months, 24 Months Change from pre-procedure
Rate of Device Success Acute/Periprocedural Successful delivery, balloon inflation, deflation and retrieval of the intact study device
Rate of Procedure Success Acute/Periprocedural Device Success or Technical Success and the absence of procedural complications.
Amputation Free Survival 6 Months, 12 Months, 24 Months Rate of subjects not requiring major amputations
EQ-5D 30 Days, 6 Months, 12 Months, 24 Months 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'Number of Participants with Primary Patency 30 Days, 6 Months, 12 Months, 24 Months 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.
Hemodynamic outcomes 30 Days, 6 Months, 12 Months, 24 Months Change in ankle brachial index (ABI) and toe pressure from pre-procedure.
Vascular Quality of Life Questionnaire (VascuQol) 30 Days, 6 Months, 12 Months, 24 Months 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.
Trial Locations
- Locations (8)
Royal Perth Hospital
🇦🇺Perth, Australia
Prince of Wales Private Hospital
🇦🇺Randwick, Australia
Royal North Shore Hospital
🇦🇺St Leonards, Australia
Universitäts Klinikum Graz
🇦🇹Graz, Austria
Universitäts-Herzzentrum Freiburg Bad Krozingen
🇩🇪Bad Krozingen, Germany
MEDINOS Kliniken des Landkreises Sonneberg GmbH
🇩🇪Sonneberg, Germany
Paul Stradins University Hospital
🇱🇻Riga, Latvia
Auckland City Hospital
🇳🇿Auckland, New Zealand
Royal Perth Hospital🇦🇺Perth, Australia