Vascular DiseasesELITENCT03412942
EndovascuLar RegIstry Evaluating SafeTy, Efficacy and Patient Comfort (ELITE)
A study testing FISH SP in people with Vascular Diseases, run by Morris Innovative Incorporated at 3 sites in United States.
Trial summary
A single-center, prospective, cohort analysis of the Femoral Introducer Sheath and Hemostasis (FISH) vascular closure device will study 100 consecutive patients on which the device will be used to close the femoral artery after angiogram and/or endovascular procedure. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vascular Diseases
- What is being tested?
- FISH SP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Feb 2017to Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All patients on which a FISH device will be used for vascular closure, deemed appropriate by the Principal Investigator.
Who cannot join
- Patients on which a FISH device will not be used for vascular closure and another method will be used - deemed appropriate by the Principal Investigator (i.e. manual compressions, PerClose, AngioSeal, etc.).
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Recruiting
Florida Research Network, LLC
Gainesville, Florida, 32605
Bret Wiechmann, MD, 352-333-0939
Bret Wiechmann, MD
- Recruiting
Healient Physician Group
Leawood, Kansas, 66211
Jessica Jones, JJones01@primehealthcare.com
David Burkart, MD
- Recruiting
North Memorial
Robbinsdale, Minnesota, 55422
Ann Antolick, BSN, 763-581-6600, Ann.Antolick@northmemorial.com
Osama Ibrahim, MD
About this study
Official title: ELITE Registry: EndovascuLar RegIstry Evaluating SafeTy, Efficacy and Patient Comfort Using the FISH ExtraCellular Matrix (SIS) Closure Device
A single-center, prospective, cohort analysis of the Femoral Introducer Sheath and Hemostasis (FISH) vascular closure device will study 100 consecutive patients on which the device will be used to close the femoral artery after angiogram and/or endovascular procedure. Study will be conducted in order to establish the level of comfort and confidence that this device provides for both patients and physician in terms of hemodynamic and usage outcomes.
Read the detailed description
The learning experience of new medical device technologies is a well-defined event but varies widely by device and user. Several factors influence rate of learning, including the device, the patient population the training technique, clear communication, and the rate of usage. Previous publication have reported on the learning curve of vascular closure technologies including; AngioSeal, Perclose \& StarClose. These reports established the curve to be close to 50 experiences in order to provide predictable results.
Many prior studies have studied the safety and efficacy of vascular closure devices. However, it is substantial to also study device success when in the hands of one specific operator. This study will examine 100 consecutive subjects which the FISH vascular closure device will be used on, and examine outcomes in the following way:
Primary Endpoint:
- Safety: Severe adverse events rate (SAE) (Device related only) (transfusion/vessel occlusion)
Secondary Endpoints:
- Safety: minor adverse event rate (MAE) (Hematoma)
- Success rate (Time to Hemostasis (TTH) < 10min)
- Time to Hemostasis (TTH) mm:ss - measured from sheath pull to absence of arterial bleeding.
- Time to Ambulation (TTA) hh:mm - measured form sheath pull to walking 20 feet.
- Patient comfort - subjective measure (see scale below) measured baseline (pre-procedure/ post procedure/ 15 days and 30 days)
- Physician Confidence and Comfort (C\&C)(measured every 10 patients)
- Conditions
- Vascular Diseases
- Being tested
- FISH SP
- Keywords
- Comfort, Confidence, Usage outcomes
- Medical subject headings
- Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FISH SPDevice
The device will be used to close the femoral artery after angiogram and/or endovascular procedure.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with FISH device | Other | Vascular closure to be performed with FISH device. Receives: Device: FISH SP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Questionnaire for Major Adverse Events
Documentation of severe adverse event related to device use (transfusion/vessel occlusion)
Measured: 30 day follow-up after device used.
Secondary outcomes (6)
Safety Questionnaire for Minor Adverse Events
Documentation of minor adverse event rate related to device use (hematoma)
Measured: 30 day follow-up after device used.
Questionnaire Recording Success Rate
Recording of time to hemostasis. TTH < 10 min will signify success
Measured: Within 24 hours
Questionnaire Measuring Time to Hemostasis (TTH)
Documentation of time measured from sheath pull to absence of arterial bleeding in minutes:seconds
Measured: Within 24 hours
Questionnaire Measuring Time to Ambulation (TTA)
Documentation of time measured form sheath pull to walking 20 feet in minutes:seconds
Measured: Within 24 hours
Questionnaire for Patient Comfort
Subjective measure, measured baseline (pre-procedure/ post procedure/ 15 days and 30 days)
Measured: Within 30 days of device
Questionnaire for Physician Confidence
Measured every 10 patients
Measured: Within 30 days of device use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start1 Feb 2017
- Primary completionDec 2018 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Morris Innovative Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Deborah Heart and Lung Center
- Responsible party
- Sponsor
- Investigators
- Richard Kovach, MD, Principal investigator, Physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03412942
- Sponsor's protocol ID
- 2K17-10
- Acronym
- ELITE
- Status last verified
- Aug 2018
- First submitted
- 11 Oct 2017
- Last updated
- 20 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ELITE Registry: EndovascuLar RegIstry Evaluating SafeTy, Efficacy and Patient Comfort Using the FISH ExtraCellular Matrix (SIS) Closure Device
- ClinicalTrials.gov ID
- NCT03412942
- Acronym / sponsor ID
- ELITE / 2K17-10
- Conditions
- Vascular Diseases
- Keywords
- Comfort, Confidence, Usage outcomes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Morris Innovative IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- Deborah Heart and Lung Center
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 29 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single-center, prospective, cohort analysis of the Femoral Introducer Sheath and Hemostasis (FISH) vascular closure device will study 100 consecutive patients on which the device will be used to close the femoral artery after angiogram and/or endovascular procedure. Study will be conducted in order to establish the level of comfort and confidence that this device provides for both patients and physician in terms of hemodynamic and usage outcomes.
Detailed description
The learning experience of new medical device technologies is a well-defined event but varies widely by device and user. Several factors influence rate of learning, including the device, the patient population the training technique, clear communication, and the rate of usage. Previous publication have reported on the learning curve of vascular closure technologies including; AngioSeal, Perclose \& StarClose. These reports established the curve to be close to 50 experiences in order to provide predictable results.
Many prior studies have studied the safety and efficacy of vascular closure devices. However, it is substantial to also study device success when in the hands of one specific operator. This study will examine 100 consecutive subjects which the FISH vascular closure device will be used on, and examine outcomes in the following way:
Primary Endpoint:
- Safety: Severe adverse events rate (SAE) (Device related only) (transfusion/vessel occlusion)
Secondary Endpoints:
- Safety: minor adverse event rate (MAE) (Hematoma)
- Success rate (Time to Hemostasis (TTH) < 10min)
- Time to Hemostasis (TTH) mm:ss - measured from sheath pull to absence of arterial bleeding.
- Time to Ambulation (TTA) hh:mm - measured form sheath pull to walking 20 feet.
- Patient comfort - subjective measure (see scale below) measured baseline (pre-procedure/ post procedure/ 15 days and 30 days)
- Physician Confidence and Comfort (C\&C)(measured every 10 patients)
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with FISH device | Other | Device: FISH SPVascular closure to be performed with FISH device. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients on which a FISH device will be used for vascular closure, deemed appropriate by the Principal Investigator.
Key exclusion criteria (1 listed)
- Patients on which a FISH device will not be used for vascular closure and another method will be used - deemed appropriate by the Principal Investigator (i.e. manual compressions, PerClose, AngioSeal, etc.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FISH SPThe device will be used to close the femoral artery after angiogram and/or endovascular procedure. | Device | Treatment with FISH device |
Primary outcome
Safety Questionnaire for Major Adverse Events
Time frame: 30 day follow-up after device used.
Documentation of severe adverse event related to device use (transfusion/vessel occlusion)
6 secondary outcomes
Safety Questionnaire for Minor Adverse Events
Time frame: 30 day follow-up after device used.
Questionnaire Recording Success Rate
Time frame: Within 24 hours
Questionnaire Measuring Time to Hemostasis (TTH)
Time frame: Within 24 hours
Questionnaire Measuring Time to Ambulation (TTA)
Time frame: Within 24 hours
Questionnaire for Patient Comfort
Time frame: Within 30 days of device
Questionnaire for Physician Confidence
Time frame: Within 30 days of device use
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Kovach, MD principal investigator
Physician
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FISH SP in people with Vascular Diseases, run by Morris Innovative Incorporated at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Linda Dewey (6098931200 ext. 5023, DeweyL@deborah.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Questionnaire for Major Adverse Events (time frame: 30 day follow-up after device used.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.