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Trial Outcomes & Findings for Safety and Performance Study of Large Hole Vascular Closure Device (NCT NCT01943344)

NCT ID: NCT01943344

Last Updated: 2018-11-02

Results Overview

Major complication rates directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation, (as defined by VARC-2).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

up to 3 Months of implantation

Results posted on

2018-11-02

Participant Flow

Participant milestones

Participant milestones
Measure
Closure Device
Subjects that receive VIVASURE CLOSURE DEVICE™ VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™
Overall Study
STARTED
12
Overall Study
COMPLETED
9
Overall Study
NOT COMPLETED
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Performance Study of Large Hole Vascular Closure Device

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Treatment
n=12 Participants
Subjects that receive VIVASURE CLOSURE DEVICE™ VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™
Age, Continuous
78 years
n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
Sex: Female, Male
Male
9 Participants
n=5 Participants
Region of Enrollment
Ireland
12 participants
n=5 Participants

PRIMARY outcome

Timeframe: up to 3 Months of implantation

Population: Two subjects died prior to 3-month follow-up, not related to the study device, hence, were not included in analysis. A third subject died prior to study completion (12 month follow-up), not related to the study device.

Major complication rates directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation, (as defined by VARC-2).

Outcome measures

Outcome measures
Measure
Treatment
n=10 Participants
Subjects that receive VIVASURE CLOSURE DEVICE™ VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™
Major Vascular Complications Directly Related to Device
0 percentage of participants

SECONDARY outcome

Timeframe: up to 3 months from implantation

Population: Two subjects died prior to 3-month follow-up, not related to the study device, hence, were not included in analysis. A third subject died prior to study completion (12 month follow-up), not related to the study device.

Incidence of minor complications directly related to the VIVASURE CLOSURE DEVICE™ up to 3 months from implantation, as defined by VARC-2.

Outcome measures

Outcome measures
Measure
Treatment
n=10 Participants
Subjects that receive VIVASURE CLOSURE DEVICE™ VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™
Minor Vascular Complications Directly Related to Device
0 percentage of Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 3 month of implantation

Population: All subjects entered into study that received the Vivasure Closure Device or had intension to treat with the Vivasure Closure Device.

Assessed by technical success rate for the VIVASURE CLOSURE DEVICE™ (Tech Success: haemostasis by investigational device, not leading to alternative treatment other than manual compression or adjunctive endovascular ballooning)

Outcome measures

Outcome measures
Measure
Treatment
n=12 Participants
Subjects that receive VIVASURE CLOSURE DEVICE™ VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™
Performance
100 percentage of successful deployments

Adverse Events

Treatment

Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Treatment
n=12 participants at risk
Subjects that receive VIVASURE CLOSURE DEVICE™ VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™
Cardiac disorders
Cardiac tamponade
8.3%
1/12 • Number of events 1
Cardiac disorders
Cardiogenic shock
8.3%
1/12 • Number of events 1
Respiratory, thoracic and mediastinal disorders
COPD
8.3%
1/12 • Number of events 1
Cardiac disorders
Chronic heart failure
33.3%
4/12 • Number of events 6
Infections and infestations
Septicemia/bacteremia
8.3%
1/12 • Number of events 1
Renal and urinary disorders
Renal failure/insufficency
8.3%
1/12 • Number of events 1
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract infection
8.3%
1/12 • Number of events 1
Blood and lymphatic system disorders
Anemia
8.3%
1/12 • Number of events 1
Musculoskeletal and connective tissue disorders
Back pain
8.3%
1/12 • Number of events 1
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
8.3%
1/12 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr Chris Martin

Vivasure Medical

Phone: +353 9 395 440

Results disclosure agreements

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