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VASCADE ANTEGRADE-PVD Post-Market Registry
trial testing Cardiva Medical VASCADE VCS in Surgical Wound in 52 participants. Completed in 18 September 2017.
| Lead sponsor | Cardiva Medical, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 52 |
| Start date | 19 January 2017 |
| Primary completion | 18 September 2017 |
| Estimated completion | 18 September 2017 |
| Sites | 5 locations across United States |
Cardiva Medical, Inc.
Adults 18 to 80, any sex, with Surgical Wound. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time to Hemostasis (TTH) is defined as elapsed time between VASCADE device removal and first observed and confirmed arterial hemostasis.
| Group | Value | 95% CI |
|---|---|---|
| VASCADE VCS | 5.87 | ± 2.44 |
Patient incident rate of combined major access site closure-related complications through 30 days
| Group | Value | 95% CI |
|---|---|---|
| VASCADE VCS | 1 |
Time to Ambulation (TTA) is defined as elapsed time between VASCADE device removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site.
| Group | Value | 95% CI |
|---|---|---|
| VASCADE VCS | 4.48 | ± 3.83 |
Time to Discharge (TTD) is defined as elapsed time between VASCADE device removal and discharge from the facility.
| Group | Value | 95% CI |
|---|---|---|
| VASCADE VCS | 5.97 | ± 5.85 |
Device Success is defined as the ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with the Cardiva VASCADE VCS alone or with adjunctive compression.
| Group | Value | 95% CI |
|---|---|---|
| VASCADE VCS | 51 |
Procedure Success is defined as attainment of Device Success and freedom from major access site closure-related complications through 30 days.
| Group | Value | 95% CI |
|---|---|---|
| VASCADE VCS | 50 |
Patient incident rate of combined minor access site closure-related complications through 30 days
| Group | Value | 95% CI |
|---|---|---|
| VASCADE VCS | 51 |
Time frame: 30 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | VASCADE VCS |
|---|---|---|
| Anemia | Blood and lymphatic system disorders | — |
| Chronic osteomyelitis of ankle/foot | Infections and infestations | — |
| Sepsis | Infections and infestations | — |
| Acute Kidney Injury | Renal and urinary disorders | — |
| Reaction | System | VASCADE VCS |
|---|---|---|
| Worsening PVD | Vascular disorders | — |
| Residual hematoma < 6 cm | Blood and lymphatic system disorders | — |
| Tissue tract oozing - prolonged | Infections and infestations | — |
| Access site arterial re-bleeding after initial hemostasis | Blood and lymphatic system disorders | — |
| Pseudoaneurysm not requiring repair | Cardiac disorders | — |
| Bruising | Skin and subcutaneous tissue disorders | — |
| Groin pain | Surgical and medical procedures | — |
| Angina | Cardiac disorders | — |
| Hypotension | Cardiac disorders | — |
| Mechanical Fall | General disorders | — |
Most-reported serious reactions: Anemia, Chronic osteomyelitis of ankle/foot, Sepsis, Acute Kidney Injury.
Data from ClinicalTrials.gov NCT02948257 adverse events section.
The objective of the registry is to collect procedural outcomes data when the Cardiva VASCADE Vascular Closure System (VCS) is used to seal femoral arterial access sites at the completion of ipsilateral peripheral interventional procedures performed through 5-7F introducer sheaths via an antegrade approach.
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/NCT02948257.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing