ClinicalTrials.gg
CompletedNCT03955653ACCESSUpdated Nov 26, 2019

Fluoroscopic-Guided Micropuncture Technique for Common Femoral Artery Access

An interventional study of Femoral artey access in Catheter Related Complication, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-11-26.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Catheter Related Complication
03

In context

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,416 studies on the registry; 278 are open to participants now.

Of its 160 completed or terminated interventional studies of FDA-regulated products, 128 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who are undergoing cardiac catheterization or PCI

Exclusion criteria

Exclusion Criteria:

  • Peripheral vascular disease
  • Renal failure, Creatinine >2.5 mg/dL
  • Hemodynamic instability, acute myocardial infarction
  • Heart failure with EF\<25%
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
200 participants (actual)

Study arms

  • Active comparator
    RAO projection

    Patients will be randomized to right anterior oblique (RAO) projection by fluoroscopy for the access to the femoral artery

    Procedure: Femoral artey access

  • Active comparator
    AP projection

    Patients will be randomized to anterior-posterior projection by fluoroscopy for the access to the femoral artery

    Procedure: Femoral artey access

Interventions

  • ProcedureFemoral artey access

    We will study the access to the femoral artery for cardiac catheterization or percutaneous coronary intervention

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: the procedure

  2. The success rate of access to the Zone III

    We will define the access to the zone III with angiography

    Time frame: the procedure

Secondary outcomes

  1. The rate of access site complications

    Hematoma, bleeding complication, femoral artery dissection, pseudoaneurysm

    Time frame: the procedure

07

Study locations

1 site
  • UAB
    Birmingham, Alabama 35294, United States
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2019 to primary completion in Oct 2019, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 16, 2019
First posted
May 20, 2019
StartActual
Apr 30, 2019
Primary completionActual
Oct 30, 2019
CompletionActual
Oct 30, 2019
Last update
Nov 26, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 26, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03955653
Responsible party
Massoud Leesar (Professor of Medicine, University of Alabama at Birmingham) — Principal investigator
First posted
May 20, 2019
Start date
Apr 30, 2019
Primary completion
Oct 30, 2019
Completion
Oct 30, 2019
Last update
Nov 26, 2019

Study contacts

Massoud A Leesar, MD
principal investigator · University of Alabama at Birmingham

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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