Trial Outcomes & Findings for CaveoVasc System - a New Femoral Vascular Access and Closure Device (NCT NCT02694549)

NCT ID: NCT02694549

Last Updated: 2018-08-28

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2018-08-28

Participant Flow

Participant milestones

Measure	CaveoVasc Patients treated with CaveoVasc System
Overall Study STARTED	12
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	CaveoVasc Patients treated with CaveoVasc System
Overall Study screen failures	2

Baseline Characteristics

CaveoVasc System - a New Femoral Vascular Access and Closure Device

Baseline characteristics by cohort

Measure	CaveoVasc n=10 Participants Patients treated with CaveoVasc System
Age, Continuous	58.1 years STANDARD_DEVIATION 11.7 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment Germany	10 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Measure	CaveoVasc n=10 Participants Patients treated with CaveoVasc System
Incidence at 30 Days After the Procedure of the Composite Endpoint of Access Site Related Major Adverse Vascular Events (MAVE).	2 Participants

PRIMARY outcome

Timeframe: 30 days

Device failure: Incidence at 30 days of bleedings requiring additional treatments of the puncture site

Outcome measures

Measure	CaveoVasc n=10 Participants Patients treated with CaveoVasc System
Primary Performance Endpoint	3 Participants

SECONDARY outcome

Timeframe: 30 days

Safety: Incidence of all adverse events at 30 days

Outcome measures

Measure	CaveoVasc n=10 Participants Patients treated with CaveoVasc System
Secondary Safety Endpoint	2 Participants

Adverse Events

CaveoVasc

Serious events: 10 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	CaveoVasc n=10 participants at risk Patients treated with CaveoVasc System
Vascular disorders High Blood Pressure	10.0% 1/10 • Number of events 1
Vascular disorders Device deficiency : Access issue	30.0% 3/10 • Number of events 3
Vascular disorders Device Deficiency : closure issue	60.0% 6/10 • Number of events 6

Other adverse events

Measure	CaveoVasc n=10 participants at risk Patients treated with CaveoVasc System
Vascular disorders Bleeding	20.0% 2/10 • Number of events 2
Vascular disorders Hematoma	20.0% 2/10 • Number of events 2
Cardiac disorders Angina Pectoris	10.0% 1/10 • Number of events 1
Vascular disorders Bleeding after procedure no compression necessary	10.0% 1/10 • Number of events 1
Vascular disorders Bleeding at the access site	10.0% 1/10 • Number of events 1
Vascular disorders Bleeding puncture site	10.0% 1/10 • Number of events 1
Vascular disorders Bleeding right groin up to 10 days after intervention	10.0% 1/10 • Number of events 1
Vascular disorders Diffuse hematoma	10.0% 1/10 • Number of events 1
Vascular disorders Hematoma and Induration right groin	10.0% 1/10 • Number of events 1
Vascular disorders Hematoma 0.9x2.3cm left groin	10.0% 1/10 • Number of events 1
Vascular disorders Hematoma right groin	10.0% 1/10 • Number of events 1
Cardiac disorders High blood pressure during procedure 199/56mmHg	10.0% 1/10 • Number of events 1
Vascular disorders not adequate placement of the device due to anatomical reason, iliac artery kinking	10.0% 1/10 • Number of events 1
Surgical and medical procedures short confusion and loss in memory due to sedation	10.0% 1/10 • Number of events 1

Additional Information

Albertus M. Scheule, MD, PhD, MBA

CaveoMed GmbH

Phone: +49(0)7071-53982-10

Email: albertus.scheule@caveomed.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place