Catheter Related ComplicationACCESSNCT03955653
Fluoroscopic-Guided Micropuncture Technique for Common Femoral Artery Access
A study testing Femoral artey access in people with Catheter Related Complication, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The main objective of this proposed study is to examine if oblique projection (20- degrees right anterior oblique (RAO) for right femoral artery access or 20-degree left anterior oblique (LAO) for left femoral artery access) is superior to anterior projection (AP) for femoral artery access in zone 2-4 and thereby… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Catheter Related Complication
- What is being tested?
- Femoral artey access
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2019to 30 Oct 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are undergoing cardiac catheterization or PCI
Who cannot join
- Peripheral vascular disease
- Renal failure, Creatinine >2.5 mg/dL
- Hemodynamic instability, acute myocardial infarction
- Heart failure with EF<25%
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluoroscopic-Guided Micropuncture Technique for Common Femoral Artery Access: Comparisons of Oblique vs. Antero-Posterior Projections for Femoral Artery Access
The main objective of this proposed study is to examine if oblique projection (20- degrees right anterior oblique (RAO) for right femoral artery access or 20-degree left anterior oblique (LAO) for left femoral artery access) is superior to anterior projection (AP) for femoral artery access in zone 2-4 and thereby resulting in lower risk of access related complications.
Read the detailed description
The investigators plan to randomize 200 subjects who present for coronary angiography, bypass graph angiography or left heart catheterization via the femoral approach. The investigators will randomly assign them to either oblique projection (20-degree RAO for right femoral artery) or 20-degree LAO (for left femoral artery) versus AP for femoral arterial access in a 1:1 fashion. A trained cardiologist will review the femoral artery angiogram. The investigators will use the scoring system used for the femoral artery access site, as previously reported (10). These predefined locations are as follows: zone 1 denotes femoral artery above the femoral head; zone 2, femoral artery from the superior border of femoral head to the center of the femoral head; zone 3, femoral artery in the center of the femoral head; zone 4, femoral artery from the center of femoral head to the inferior border of the femoral head; and zone 5, femoral artery below the inferior boarder of the femoral head.
The invesigators will use micropuncture access kit for femoral artery access. Micropuncture needle will be advanced to the center of the femoral head and common femoral artery will be punctured guided by fluoroscopy. Those assigned to oblique projection will have fluoroscopic-guided femoral access in RAO 20 degree for right femoral artery and LAO 20 degree for left femoral artery, while those assigned to AP will have femoral artery access in AP 0 degree. For both groups, the investigators will also obtain the other view as a reference to compare results (i.e., in the oblique group, we will save AP and vice versa). If the tip of the micropuncture needle were located in the femoral artery corresponding to the center (zone 3) or bottom third (zone 4) of the femoral head in the 20-degree RAO, 20-degree LAO position or zero-degree AP position, the micropuncture dilator will be advanced into the femoral artery, 0.018" guide wire will be exchanged with a 0.035" guide wire, and a sheath will be placed in the femoral artery, and the femoral angiography will be performed in the 20-degree RAO or 20-degree LAO projection for right and left femoral artery, respectively.
The investigators will also collect data on demographic characteristics including age, race, gender, as well as cardiovascular risk factors such as history of diabetes, hypertension, dyslipidemia, peripheral arterial disease, prior CAD, prior CVA, smoking history, family history of CAD, eGFR. We will also obtain data on medication history to review if they are on antiplatelet or anticoagulants. Those with ipsilateral access within the past 90 days will be excluded.
- Conditions
- Catheter Related Complication
- Being tested
- Femoral artey access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral artey accessProcedure or surgery
We will study the access to the femoral artery for cardiac catheterization or percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| RAO projection | Active comparator | Patients will be randomized to right anterior oblique (RAO) projection by fluoroscopy for the access to the femoral artery Receives: Procedure: Femoral artey access |
| AP projection | Active comparator | Patients will be randomized to anterior-posterior projection by fluoroscopy for the access to the femoral artery Receives: Procedure: Femoral artey access |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of access to the central portion of the femoral artery (Zone III)
We will assess the access to the center of the femoral artery after insertion of the sheath for heart catheterization or PCI
Measured: the procedure
The success rate of access to the Zone III
We will define the access to the zone III with angiography
Measured: the procedure
Secondary outcomes (1)
The rate of access site complications
Hematoma, bleeding complication, femoral artery dissection, pseudoaneurysm
Measured: the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start30 Apr 2019
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Catheter Related ComplicationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized equally to the right anterior oblique view using fluoroscopy and the access to the femoral artery will be compared to that in the anterior-posterior projection
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Massoud Leesar, University of Alabama at Birmingham
- Investigators
- Massoud A Leesar, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955653
- Sponsor's protocol ID
- IRB-300001879
- Acronym
- ACCESS
- Status last verified
- May 2019
- First submitted
- 16 May 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leesar MA, Waheed S, Al Solaiman F, Chatterjee A, Daya HA, Hage FG, Brott BC. Randomized trial of an oblique versus standard fluoroscopic-guided micropuncture technique for femoral arterial access: The Micropuncture-CFA trial. Cardiovasc Revasc Med. 2023 Dec;57:43-50. doi: 10.1016/j.carrev.2023.06.029. Epub 2023 Jun 28.
PubMed 37414613
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluoroscopic-Guided Micropuncture Technique for Common Femoral Artery Access: Comparisons of Oblique vs. Antero-Posterior Projections for Femoral Artery Access
- ClinicalTrials.gov ID
- NCT03955653
- Acronym / sponsor ID
- ACCESS / IRB-300001879
- Conditions
- Catheter Related Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 20 May 2019 (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.
The main objective of this proposed study is to examine if oblique projection (20- degrees right anterior oblique (RAO) for right femoral artery access or 20-degree left anterior oblique (LAO) for left femoral artery access) is superior to anterior projection (AP) for femoral artery access in zone 2-4 and thereby resulting in lower risk of access related complications.
Detailed description
The investigators plan to randomize 200 subjects who present for coronary angiography, bypass graph angiography or left heart catheterization via the femoral approach. The investigators will randomly assign them to either oblique projection (20-degree RAO for right femoral artery) or 20-degree LAO (for left femoral artery) versus AP for femoral arterial access in a 1:1 fashion. A trained cardiologist will review the femoral artery angiogram. The investigators will use the scoring system used for the femoral artery access site, as previously reported (10). These predefined locations are as follows: zone 1 denotes femoral artery above the femoral head; zone 2, femoral artery from the superior border of femoral head to the center of the femoral head; zone 3, femoral artery in the center of the femoral head; zone 4, femoral artery from the center of femoral head to the inferior border of the femoral head; and zone 5, femoral artery below the inferior boarder of the femoral head.
The invesigators will use micropuncture access kit for femoral artery access. Micropuncture needle will be advanced to the center of the femoral head and common femoral artery will be punctured guided by fluoroscopy. Those assigned to oblique projection will have fluoroscopic-guided femoral access in RAO 20 degree for right femoral artery and LAO 20 degree for left femoral artery, while those assigned to AP will have femoral artery access in AP 0 degree. For both groups, the investigators will also obtain the other view as a reference to compare results (i.e., in the oblique group, we will save AP and vice versa). If the tip of the micropuncture needle were located in the femoral artery corresponding to the center (zone 3) or bottom third (zone 4) of the femoral head in the 20-degree RAO, 20-degree LAO position or zero-degree AP position, the micropuncture dilator will be advanced into the femoral artery, 0.018" guide wire will be exchanged with a 0.035" guide wire, and a sheath will be placed in the femoral artery, and the femoral angiography will be performed in the 20-degree RAO or 20-degree LAO projection for right and left femoral artery, respectively.
The investigators will also collect data on demographic characteristics including age, race, gender, as well as cardiovascular risk factors such as history of diabetes, hypertension, dyslipidemia, peripheral arterial disease, prior CAD, prior CVA, smoking history, family history of CAD, eGFR. We will also obtain data on medication history to review if they are on antiplatelet or anticoagulants. Those with ipsilateral access within the past 90 days will be excluded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized equally to the right anterior oblique view using fluoroscopy and the access to the femoral artery will be compared to that in the anterior-posterior projection
| Arm | Type | Receives |
|---|---|---|
| RAO projection | Active comparator | Procedure: Femoral artey accessPatients will be randomized to right anterior oblique (RAO) projection by fluoroscopy for the access to the femoral artery |
| AP projection | Active comparator | Procedure: Femoral artey accessPatients will be randomized to anterior-posterior projection by fluoroscopy for the access to the femoral artery |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are undergoing cardiac catheterization or PCI
Key exclusion criteria (4 listed)
- Peripheral vascular disease
- Renal failure, Creatinine >2.5 mg/dL
- Hemodynamic instability, acute myocardial infarction
- Heart failure with EF<25%
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 |
|---|---|---|
| Femoral artey accessWe will study the access to the femoral artery for cardiac catheterization or percutaneous coronary intervention | Procedure or surgery | AP projection, RAO projection |
Primary outcome
The percentage of access to the central portion of the femoral artery (Zone III)
Time frame: the procedure
We will assess the access to the center of the femoral artery after insertion of the sheath for heart catheterization or PCI
The success rate of access to the Zone III
Time frame: the procedure
We will define the access to the zone III with angiography
1 secondary outcome
The rate of access site complications
Time frame: the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Derived from this study: PubMed 37414613Leesar MA, Waheed S, Al Solaiman F, Chatterjee A, Daya HA, Hage FG, Brott BC. Randomized trial of an oblique versus standard fluoroscopic-guided micropuncture technique for femoral arterial access: The Micropuncture-CFA trial. Cardiovasc Revasc Med. 2023 Dec;57:43-50. doi: 10.1016/j.carrev.2023.06.029. Epub 2023 Jun 28.
- Individual participant dataSharing planned: No
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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.
Massoud A Leesar, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femoral artey access in people with Catheter Related Complication, run by University of Alabama at Birmingham at 1 site 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 4 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: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The percentage of access to the central portion of the femoral artery (Zone III) (time frame: the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03955653, which also lists 1 linked publication.
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 26 Nov 2019.