Safety and Feasibility of Surmodics SUNDANCE™ Drug Coated Balloon (SWING)
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|ClinicalTrials.gov Identifier: NCT04107298|
Recruitment Status : Not yet recruiting
First Posted : September 27, 2019
Last Update Posted : October 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease Critical Lower Limb Ischemia||Device: SUNDANCE™ Drug Coated Balloon||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official 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|
|Estimated Study Start Date :||February 15, 2020|
|Estimated Primary Completion Date :||January 1, 2021|
|Estimated Study Completion Date :||July 1, 2023|
Experimental: SUNDANCE™ Drug Coated Balloon
SUNDANCE™ Drug Coated Balloon
Device: SUNDANCE™ Drug Coated Balloon
Angioplasty procedure with a sirolimus-coated, percutaneous transluminal angioplasty (PTA) balloon catheter
- Primary Safety Endpoint: Number of Participants with a composite of freedom from Major Adverse Limb Event (MALE) and perioperative death [ Time Frame: 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) [ Time Frame: 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.
- Rate of Device Success [ Time Frame: Acute/Periprocedural ]Successful delivery, balloon inflation, deflation and retrieval of the intact study device
- Rate of Technical Success [ Time Frame: 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 Procedure Success [ Time Frame: Acute/Periprocedural ]Device Success or Technical Success and the absence of procedural complications.
- Rate of Restenosis [ Time Frame: 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.
- Number of Participants with Primary Patency [ Time Frame: 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.
- Major Adverse Event (MAE) rate [ Time Frame: 30 Days, 6 Months, 12 Months, 24 Months ]Composite rate of all-cause death, target limb major amputation and CD-TLR.
- Amputation Free Survival [ Time Frame: 6 Months, 12 Months, 24 Months ]Rate of subjects not requiring major amputations
- Hemodynamic outcomes [ Time Frame: 30 Days, 6 Months, 12 Months, 24 Months ]Change in ankle brachial index (ABI) and toe pressure from pre-procedure.
- Change in Rutherford-Becker Classification [ Time Frame: 30 Days, 6 Months, 12 Months, 24 Months ]Change from pre-procedure
- EQ-5D [ Time Frame: 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'
- Walking Impairment Questionnaire (WIQ) [ Time Frame: 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.
- Vascular Quality of Life Questionnaire (VascuQol) [ Time Frame: 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.
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): NCT04107298
|Contact: Aaron Jacobson, DC, CCRPfirstname.lastname@example.org|
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