Trial Outcomes & Findings for Safety and Efficacy of the SurVeil™ Drug-Coated Balloon (AVess FIH) (NCT NCT03734679)

NCT ID: NCT03734679

Last Updated: 2025-02-06

Results Overview

Freedom from clinically-driven target lesion revascularization (CD-TLR) or access thrombosis

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2025-02-06

Participant Flow

Participants were recruited at two sites: site 100 - Prince of Wales Hospital, NSW Australia and site 101- Auckland City Hospital, Auckland, NZ. The first subject was enrolled at Site 100 on 5 Dec 2018, and at Site 101 on 12 Feb 2019. The last subject enrolled on 20 August 2019.

A total of thirteen (13) subjects were consented with the EC-approved informed consent for the trial; twelve (12) were enrolled and treated within the study and one (1) subject was a screen failure.

Participant milestones

Measure	SurVeil Drug Coated Balloon Participants were recruited at two sites: site 100 - Prince of Wales Hospital, NSW Australia and site 101- Auckland City Hospital, Auckland, NZ. The first subject was enrolled at Site 100 on 5 Dec 2018, and at Site 101 on 12 Feb 2019. The last subject enrolled on 20 August 2019.
Overall Study STARTED	12
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	SurVeil Drug Coated Balloon Participants were recruited at two sites: site 100 - Prince of Wales Hospital, NSW Australia and site 101- Auckland City Hospital, Auckland, NZ. The first subject was enrolled at Site 100 on 5 Dec 2018, and at Site 101 on 12 Feb 2019. The last subject enrolled on 20 August 2019.
Overall Study Missed Visit	1

Baseline Characteristics

Safety and Efficacy of the SurVeil™ Drug-Coated Balloon (AVess FIH)

Baseline characteristics by cohort

Measure	SurVeil Drug Coated Balloon n=12 Participants Percutaneous transluminal angioplasty will be performed using the SurVeil™ Drug Coated Balloon (SurVeil DCB).
Age, Continuous	61.2 years STANDARD_DEVIATION 12.73 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	7 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
BMI	30.3 kg/m² STANDARD_DEVIATION 6.74 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Freedom from clinically-driven target lesion revascularization (CD-TLR) or access thrombosis

Outcome measures

Measure	SurVeil Drug Coated Balloon n=12 Participants Percutaneous transluminal angioplasty will be performed using the SurVeil™ Drug Coated Balloon (SurVeil DCB).
Number of Participants With Target Lesion Primary Patency at 6 Months Post Procedure	11 Participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	SurVeil Drug Coated Balloon n=12 Participants Percutaneous transluminal angioplasty will be performed using the SurVeil™ Drug Coated Balloon (SurVeil DCB).
Number of Participants With Absence of All Cause Death up to 30 Days (CEC Adjudicated)	12 Participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	SurVeil Drug Coated Balloon n=12 Participants Percutaneous transluminal angioplasty will be performed using the SurVeil™ Drug Coated Balloon (SurVeil DCB).
Number and Rate of Patients With Device and Procedure Related Adverse Events (CEC Adjudicated)	1 Participants

SECONDARY outcome

Timeframe: Through 6 months

Population: Three subjects did not have secondary functional assessed at six (6) months. One subject missed the 6-month visit. One subject underwent a kidney transplant prior to the six (6) month visit, therefore, this subject was not undergoing dialysis at this time. One subject was granted a protocol waiver by the Sponsor for trial enrollment. This subject had a mature fistula that had a treatable stenotic lesion for study entry; which has not been used for dialysis through the 6-month time period.

Secondary Patency is defined as supporting hemodialysis with a pump speed of at least 300ml/min through 6 months.

Outcome measures

Measure	SurVeil Drug Coated Balloon n=9 Participants Percutaneous transluminal angioplasty will be performed using the SurVeil™ Drug Coated Balloon (SurVeil DCB).
Number of Participants With Secondary Functional Patency	7 Participants

SECONDARY outcome

Timeframe: 30 days and 6 months

Outcome measures

Measure	SurVeil Drug Coated Balloon n=12 Participants Percutaneous transluminal angioplasty will be performed using the SurVeil™ Drug Coated Balloon (SurVeil DCB).
Number of Participants With Subsequent Reinterventions, Such as Angioplasty, Stent, Fistula, That Are Required to Maintain Target Lesion Patency (CEC-Adjudicated) Through 30-Day visit	0 Participants
Number of Participants With Subsequent Reinterventions, Such as Angioplasty, Stent, Fistula, That Are Required to Maintain Target Lesion Patency (CEC-Adjudicated) Through 6-Month	1 Participants

SECONDARY outcome

Timeframe: 30 days

Patency is defined as <50% restenosis within the target lesion.

Outcome measures

Measure	SurVeil Drug Coated Balloon n=12 Participants Percutaneous transluminal angioplasty will be performed using the SurVeil™ Drug Coated Balloon (SurVeil DCB).
Number of Participants With Patency of Target Lesion as Defined by Duplex Ultrasound (Reported by DUS Core Lab)	11 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Two subjects were not included in the 6-month secondary endpoint analysis. One subject missed 6-month follow-up visit. One subject required an intervention to maintain patency during the 6-month timeframe.

Patency is defined as <50% restenosis within the target lesion.

Outcome measures

Measure	SurVeil Drug Coated Balloon n=10 Participants Percutaneous transluminal angioplasty will be performed using the SurVeil™ Drug Coated Balloon (SurVeil DCB).
Number of Participants With Patency of Target Lesion as Defined by Duplex Ultrasound (Reported by DUS Core Lab)	2 Participants

Adverse Events

Surveil Drug Coated Balloon

Serious events: 8 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Surveil Drug Coated Balloon n=12 participants at risk SurVeil Drug Coated Balloon: Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
Surgical and medical procedures Renal transplant	8.3% 1/12 • Number of events 1 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related
Vascular disorders Haematoma NOS	8.3% 1/12 • Number of events 1 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related
General disorders Physical deconditioning	8.3% 1/12 • Number of events 1 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related
Injury, poisoning and procedural complications Restenosis	16.7% 2/12 • Number of events 2 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related
Psychiatric disorders Insomnia	8.3% 1/12 • Number of events 1 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related
Psychiatric disorders Confusion	8.3% 1/12 • Number of events 1 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related
Infections and infestations Folliculitis	8.3% 1/12 • Number of events 1 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related
Vascular disorders Heel ulcer	8.3% 1/12 • Number of events 1 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related
Cardiac disorders Paroxysmal atrial fibrillation	8.3% 1/12 • Number of events 1 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related
Infections and infestations Abscess	8.3% 1/12 • Number of events 1 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related
Gastrointestinal disorders Diarrhea	8.3% 1/12 • Number of events 1 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related
Vascular disorders Ischaemia NOS	8.3% 1/12 • Number of events 1 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related
Infections and infestations Osteomyelitis of the foot	8.3% 1/12 • Number of events 1 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related

Other adverse events

Measure	Surveil Drug Coated Balloon n=12 participants at risk SurVeil Drug Coated Balloon: Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
Musculoskeletal and connective tissue disorders Pain in elbow	8.3% 1/12 • Number of events 1 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related
Gastrointestinal disorders Tooth pain	8.3% 1/12 • Number of events 1 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related
Infections and infestations Viral infection NOS	8.3% 1/12 • Number of events 1 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related
Ear and labyrinth disorders Hearing loss unilateral	8.3% 1/12 • Number of events 1 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related
Injury, poisoning and procedural complications Restenosis	25.0% 3/12 • Number of events 3 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related
Respiratory, thoracic and mediastinal disorders Shortness of breath	16.7% 2/12 • Number of events 2 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related
Ear and labyrinth disorders Vertigo	8.3% 1/12 • Number of events 1 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related
Vascular disorders Heel ulcer	8.3% 1/12 • Number of events 1 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related
Nervous system disorders Cerebellar lesion NOS	8.3% 1/12 • Number of events 1 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related
Psychiatric disorders Cognitive impairment	8.3% 1/12 • Number of events 1 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related
Metabolism and nutrition disorders Fluid overload	8.3% 1/12 • Number of events 1 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related
Injury, poisoning and procedural complications Vein rupture	8.3% 1/12 • Number of events 1 • All site-reported adverse events and Serious Adverse Events (Site Reported vs. CEC Adjudicated) through 6-months, including those found to be device-related (Serious Adverse Device Effect) or procedure-related

Additional Information

Thu Huyen Ha

Surmodics

Phone: 952.500.7261

Email: tha@surmodics.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PI agrees that no publication may be made until Publication of the results of the multi-center Study or 2 years after Study Completion, whichever is the sooner. The PI must give a copy of any proposed publication to the Sponsor at least 40 days prior to public release. The sponsor may provide comments on the proposed publication, which the PI will not be bound to follow them.
• Publication restrictions are in place

Restriction type: OTHER