Fluoroscopic-Guided Micropuncture Technique for Common Femoral Artery Access
Condition: Catheter Related Complication
Study type: Interventional

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.
    

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.
    

Intervention name(s): Femoral artey access
Intervention type(s): Procedure
Intervention description(s): We will study the access to the femoral artery for cardiac catheterization or percutaneous coronary intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Diagnostic