ComplicationsFEMORISNCT01103141
Femoral Micropuncture or Routine Introducer Study
A study testing Micropuncture needle set and Standard gauge-18 needle set in people with Complications, run by Cook Group Incorporated at 2 sites in United States.
Trial summary
FEMORIS is a marketing study approved by institutional review boards to compare the rates of complications found when using either the Micropuncture® needle introducer or a standard gauge-18 needle to access the groin blood vessels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Complications
- What is being tested?
- Micropuncture needle set and Standard gauge-18 needle set
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2010to Apr 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Undergoing left heart catheterization with anticipated or possible percutaneous coronary intervention
Who cannot join
- Left heart cardiac catheterization purely for diagnostic purposes where percutaneous coronary intervention is not anticipated
- Catheterization utilizes primary vascular access site other than the groin
- Catheterization is intended for right heart procedure alone or combined with left and right heart procedures
- Age less than 18 years
- Patient has planned intervention or access utilizing the same groin within 14 days
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, San Francisco, Fresno, School of Medicine
Fresno, California, 93701
St. Vincent Hospital
Indianapolis, Indiana, 46290
About this study
FEMORIS is a marketing study approved by institutional review boards to compare the rates of complications found when using either the Micropuncture® needle introducer or a standard gauge-18 needle to access the groin blood vessels.
- Conditions
- Complications
- Being tested
- Micropuncture needle set, Standard gauge-18 needle set
- Keywords
- Vascular Surgical Procedures, Angioplasty, Radiology, Interventional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micropuncture needle setDevice
Groin access for vascular intervention
Standard gauge-18 needle setDevice
Groin access for vascular intervention
| Study group | Role | What they receive |
|---|---|---|
| Micropuncture | Active comparator | Not described Receives: Device: Micropuncture needle set |
| Standard | Active comparator | Not described Receives: Device: Standard gauge-18 needle set |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Peripheral Vascular Events
Major peripheral vascular events occurring during femoral catheterization followed by Percutaneous Coronary Intervention (PCI), which include any of the following: Groin bleeding, including oozing or spurting after standard compression time necessitating further compression; Groin hematoma ≥ 5 cm at any time during or after the procedure; Pseudoaneurysm, confirmed by Doppler ultrasound; Arteriovenous (AV) fistula, confirmed by Doppler ultrasound; Arterial dissection, thrombosis, or embolism; Retroperitoneal bleeding defined by Computed Tomography Angiography (CTA) or surgery; Significant drop in hemoglobin ≥ 3 g/dL, or a drop in hematocrit ≥ 10% within 24-48 hours after the procedure compared to baseline without an obvious non-groin source; Any groin complication delaying hospital discharge; Large ecchymosis (> 15 cm) at the site of vascular access on follow-up (dark purple to black and confluent ecchymoses); Obvious extravascular extravasation of contrast as noted on the femoral
Measured: 7 - 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2011
- Study completionApr 2011
Why it stopped: This original design is no longer consistent with current clinical practice.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ComplicationsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook Group Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103141
- Sponsor's protocol ID
- 09-012
- Acronym
- FEMORIS
- Status last verified
- Apr 2017
- First submitted
- 12 Apr 2010
- Last updated
- 11 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral Micropuncture or Routine Introducer Study
- ClinicalTrials.gov ID
- NCT01103141
- Acronym / sponsor ID
- FEMORIS / 09-012
- Conditions
- Complications
- Keywords
- Vascular Surgical Procedures, Angioplasty, Radiology, Interventional
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This original design is no longer consistent with current clinical practice.
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Cook Group IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 14 Apr 2010 (estimated)
- Results
- Posted 4 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
FEMORIS is a marketing study approved by institutional review boards to compare the rates of complications found when using either the Micropuncture® needle introducer or a standard gauge-18 needle to access the groin blood vessels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Micropuncture | Active comparator | Device: Micropuncture needle set |
| Standard | Active comparator | Device: Standard gauge-18 needle set |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Undergoing left heart catheterization with anticipated or possible percutaneous coronary intervention
Key exclusion criteria (5 listed)
- Left heart cardiac catheterization purely for diagnostic purposes where percutaneous coronary intervention is not anticipated
- Catheterization utilizes primary vascular access site other than the groin
- Catheterization is intended for right heart procedure alone or combined with left and right heart procedures
- Age less than 18 years
- Patient has planned intervention or access utilizing the same groin within 14 days
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 |
|---|---|---|
| Micropuncture needle setGroin access for vascular intervention | Device | Micropuncture |
| Standard gauge-18 needle setGroin access for vascular intervention | Device | Standard |
Primary outcome
Major Peripheral Vascular Events
Time frame: 7 - 14 days
Major peripheral vascular events occurring during femoral catheterization followed by Percutaneous Coronary Intervention (PCI), which include any of the following: Groin bleeding, including oozing or spurting after standard compression time necessitating further compression; Groin hematoma ≥ 5 cm at any time during or after the procedure; Pseudoaneurysm, confirmed by Doppler ultrasound; Arteriovenous (AV) fistula, confirmed by Doppler ultrasound; Arterial dissection, thrombosis, or embolism; Retroperitoneal bleeding defined by Computed Tomography Angiography (CTA) or surgery; Significant drop in hemoglobin ≥ 3 g/dL, or a drop in hematocrit ≥ 10% within 24-48 hours after the procedure compared to baseline without an obvious non-groin source; Any groin complication delaying hospital discharge; Large ecchymosis (> 15 cm) at the site of vascular access on follow-up (dark purple to black and confluent ecchymoses); Obvious extravascular extravasation of contrast as noted on the femoral
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micropuncture needle set and Standard gauge-18 needle set in people with Complications, run by Cook Group Incorporated at 2 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 5 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: stopped early, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 4 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Peripheral Vascular Events (time frame: 7 - 14 days). 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 11 May 2017.