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Safety and Efficacy of the SurVeil™ Drug-Coated Balloon (AVess FIH)
NA trial testing SurVeil Drug Coated Balloon in Hemodialysis Access Failure in 12 participants. Completed in 24 July 2024.
| Lead sponsor | SurModics, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 5 December 2018 |
| Primary completion | 19 February 2020 |
| Estimated completion | 24 July 2024 |
| Sites | 2 locations across New Zealand, Australia |
SurModics, Inc.
18 and older, any sex, with Hemodialysis Access Failure. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Freedom from clinically-driven target lesion revascularization (CD-TLR) or access thrombosis
| Group | Value | 95% CI |
|---|---|---|
| SurVeil Drug Coated Balloon | 11 |
| Group | Value | 95% CI |
|---|---|---|
| SurVeil Drug Coated Balloon | 12 |
| Group | Value | 95% CI |
|---|---|---|
| SurVeil Drug Coated Balloon | 1 |
Secondary Patency is defined as supporting hemodialysis with a pump speed of at least 300ml/min through 6 months.
| Group | Value | 95% CI |
|---|---|---|
| SurVeil Drug Coated Balloon | 7 |
| Group | Value | 95% CI |
|---|---|---|
| SurVeil Drug Coated Balloon | 0 |
| Group | Value | 95% CI |
|---|---|---|
| SurVeil Drug Coated Balloon | 1 |
Patency is defined as \<50% restenosis within the target lesion.
| Group | Value | 95% CI |
|---|---|---|
| SurVeil Drug Coated Balloon | 11 |
Patency is defined as \<50% restenosis within the target lesion.
| Group | Value | 95% CI |
|---|---|---|
| SurVeil Drug Coated Balloon | 2 |
Time frame: 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. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Surveil Drug Coated Balloon |
|---|---|---|
| Restenosis | Injury, poisoning and procedural complications | — |
| Renal transplant | Surgical and medical procedures | — |
| Haematoma NOS | Vascular disorders | — |
| Physical deconditioning | General disorders | — |
| Insomnia | Psychiatric disorders | — |
| Confusion | Psychiatric disorders | — |
| Folliculitis | Infections and infestations | — |
| Heel ulcer | Vascular disorders | — |
| Paroxysmal atrial fibrillation | Cardiac disorders | — |
| Abscess | Infections and infestations | — |
| Diarrhea | Gastrointestinal disorders | — |
| Ischaemia NOS | Vascular disorders | — |
| Osteomyelitis of the foot | Infections and infestations | — |
| Reaction | System | Surveil Drug Coated Balloon |
|---|---|---|
| Restenosis | Injury, poisoning and procedural complications | — |
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | — |
| Pain in elbow | Musculoskeletal and connective tissue disorders | — |
| Tooth pain | Gastrointestinal disorders | — |
| Viral infection NOS | Infections and infestations | — |
| Hearing loss unilateral | Ear and labyrinth disorders | — |
| Vertigo | Ear and labyrinth disorders | — |
| Heel ulcer | Vascular disorders | — |
| Cerebellar lesion NOS | Nervous system disorders | — |
| Cognitive impairment | Psychiatric disorders | — |
| Fluid overload | Metabolism and nutrition disorders | — |
| Vein rupture | Injury, poisoning and procedural complications | — |
Most-reported serious reactions: Restenosis, Renal transplant, Haematoma NOS, Physical deconditioning, Insomnia, Confusion, Folliculitis, Heel ulcer.
Data from ClinicalTrials.gov NCT03734679 adverse events section.
The purpose of this study is to evaluate the safety and performance of the SurVeil DCB in subjects with obstructive lesions of arteriovenous fistulae for hemodialysis.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03734679.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing