Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000791831
Ethics application status
Approved
Date submitted
13/04/2021
Date registered
23/06/2021
Date last updated
30/05/2023
Date data sharing statement initially provided
23/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Percutaneous Decannulation of Extracorporeal Membrane Oxygenation Using MANTA Vascular Closure Device
Scientific title
Feasibility of Percutaneous Decannulation of Extracorporeal Membrane Oxygenation Using MANTA Vascular Closure Device in Adults
Secondary ID [1] 303896 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Extracorporeal Membrane Oxygenation 321474 0
Condition category
Condition code
Cardiovascular 319235 319235 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following VA-ECMO decannulation, the MANTA Vascular Closure Device will be used for percutaneous closure of the large bore arterial cannula site (as opposed to open surgery). The percutaneous closure will be performed by an interventional cardiologist in the cardiac catheter laboratory with an intensive care specialist and cardiothoracic or vascular surgeon on standby. The intervention will be delivered once. A Teleflex Medical (device manufacturer) representative will be available to the interventional team to ensure that the device is used in keeping with manufacturer specifics.
Intervention code [1] 320200 0
Treatment: Devices
Comparator / control treatment
No control (single arm feasibility study)
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327104 0
Puncture closure without the use of surgical or additional endovascular intervention

Assessment: Trial team notification by the multidisciplinary medical team, patient medical records.
Timepoint [1] 327104 0
72 hours
Secondary outcome [1] 393797 0
Access site or access-related vascular injury (dissection, stenosis, perforation, rupture, AV fistula, pseudoaneurysm, haematoma, irreversible nerve injury, compartment syndrome, percutaneous closure device failure)

Assessment: Trial team notification by the multidisciplinary medical team, investigations as per the standard of care (if conducted by the treating team), patient medical records.
Timepoint [1] 393797 0
30 days
Secondary outcome [2] 393798 0
Distal embolization requiring surgery or resulting in amputation or irreversible end-organ damage

Assessment: Trial team notification by the multidisciplinary medical team, patient medical records.
Timepoint [2] 393798 0
30 days
Secondary outcome [3] 393799 0
Unplanned endovascular or surgical intervention associated with death, major bleeding, visceral ischaemia or neurological impairment

Assessment: Trial team notification by the multidisciplinary medical team, patient medical records.
Timepoint [3] 393799 0
30 days
Secondary outcome [4] 393800 0
Any new ipsilateral lower extremity ischaemia

Assessment: Trial team notification by the multidisciplinary medical team, patient medical records.
Timepoint [4] 393800 0
30 days
Secondary outcome [5] 393801 0
Surgery for access site-related nerve injury or permanent access site related nerve injury

Assessment: Trial team notification by the multidisciplinary medical team, patient medical records.
Timepoint [5] 393801 0
30 days
Secondary outcome [6] 393802 0
Life threatening or disabling bleeding (BARC 3b, 3c, 5)

Assessment: Trial team notification by the multidisciplinary medical team, investigations as per the standard of care (if conducted by the treating team), patient medical records.
Timepoint [6] 393802 0
30 days
Secondary outcome [7] 393803 0
Major bleeding (BARC 3a)

Assessment: Trial team notification by the multidisciplinary medical team, investigations as per the standard of care (if conducted by the treating team), patient medical records.
Timepoint [7] 393803 0
30 days
Secondary outcome [8] 393804 0
Access site related infection requiring intravenous antibiotics

Assessment: Trial team notification by the multidisciplinary medical team, investigations as per the standard of care (if conducted by the treating team), patient medical records.
Timepoint [8] 393804 0
30 days

Eligibility
Key inclusion criteria
- Deemed appropriate by the multi-disciplinary team discussion including ICU physician, cardiothoracic surgeon, vascular surgeon, and interventional cardiologist.
- Suitable vascular anatomy as established by vascular ultrasound.
- Suitable body habitus (body mass index >20kg/m2 and <40 kg/m2).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Non femoral ECMO.
- Thrombus in CFA/SFA .
- Track depth on ultrasound exceeding 7cm.
- Puncture site of arterial cannula close to bifurcation , or other unfavourable features such as heavily calcified CFA.
- Arterial re-cannulation cases.
- ECMO > 14 days in situ.
- Known bleeding disorder including thrombocytopenia (platelet count <50 000 cells/µL), thrombasthenia, haemophilia, von Willebrand disease.
- Cannula site infection.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As this is a pilot study, only descriptive statistics will be used. Normally distributed continuous data will be expressed as mean (± SD). Non-normally distributed data will be expressed in median (range). Categorical variables will be expressed as number (percentage).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2022
Actual
1/11/2022
Date of last participant enrolment
Anticipated
1/06/2023
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
20
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19064 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 33614 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 308284 0
Commercial sector/Industry
Name [1] 308284 0
Teleflex Medical Australia
Country [1] 308284 0
Australia
Primary sponsor type
Individual
Name
Antony Walton
Address
Department of Cardiology
Alfred Hospital
Heart Centre, Level 3 Phillip Block, 55 Commercial Road, Melbourne, VIC, 3004
Country
Australia
Secondary sponsor category [1] 309088 0
Individual
Name [1] 309088 0
Vincent Pellegrino
Address [1] 309088 0
Intensive Care Unit
Alfred Hospital
55 Commercial Road, Melbourne, VIC, 3004
Country [1] 309088 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308258 0
Alfred HREC
Ethics committee address [1] 308258 0
55 Commercial Road, Melbourne, VIC, 3004
Ethics committee country [1] 308258 0
Australia
Date submitted for ethics approval [1] 308258 0
26/04/2021
Approval date [1] 308258 0
27/05/2021
Ethics approval number [1] 308258 0

Summary
Brief summary
VA-ECMO is a life-saving therapy in patients with cardiovascular or respiratory failure. The use of VA-ECMO is increasing and has doubled globally in the last 5 years. Percutaneous cannulation can be achieved using ultrasound guidance, even in unfavourable clinical and/or environmental conditions. If the patient recovers and can be weaned from VA-ECMO, or if ongoing VA-ECMO support is futile and no longer meets its intended goals, withdrawal of the VA-ECMO is required. Removal of the large (15-21F) femoral arterial cannulas is typically performed in an open surgical procedure. However, surgical decannulation is associated with several complications such as bleeding, delayed wound healing and infections. In addition, there is an increased strain on healthcare resources: patients need a vascular or cardiac surgeon, general anaesthesia, theatre time with support of a perfusionist, and transport to and from the theatre.

To circumvent this, manual compression and suture-based vascular closure devices have been used in VA-ECMO decannulation, but both were associated with an increased risk of bleeding (5-10%) or requiring additional steps during initial VA-ECMO cannulation. The MANTA vascular closure device is a collagen plug based device, that is increasingly used in large bore interventional therapies such as transcatheter aortic valve implantation, endovascular aneurysm repair or periprocedural of left ventricular assist devices.

This is a non-randomised open-label feasibility study. We aim to include 20 patients on VA-ECMO in which decannulation of ECMO support is pursued by the treating team, to investigate the safety and feasibility of percutaneous decannulation of femoral VA-ECMO using the MANTA VCD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 110106 0
A/Prof Antony Walton
Address 110106 0
Department of Cardiology
Alfred Health
Heart Centre, Level 3 Phillip Block, 55 Commercial Road, Melbourne, VIC, 3004
Country 110106 0
Australia
Phone 110106 0
+61 3 9426 6693
Fax 110106 0
Email 110106 0
[email protected]
Contact person for public queries
Name 110107 0
A/Prof Antony Walton
Address 110107 0
Department of Cardiology
Alfred Health
Heart Centre, Level 3 Phillip Block, 55 Commercial Road, Melbourne, VIC, 3004
Country 110107 0
Australia
Phone 110107 0
+61 3 9426 6693
Fax 110107 0
Email 110107 0
[email protected]
Contact person for scientific queries
Name 110108 0
A/Prof Antony Walton
Address 110108 0
Department of Cardiology
Alfred Health
Heart Centre, Level 3 Phillip Block, 55 Commercial Road, Melbourne, VIC, 3004
Country 110108 0
Australia
Phone 110108 0
+61 3 9426 6693
Fax 110108 0
Email 110108 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.