Comparing TR Band to Statseal in Conjunction With TR Band

This study is a physician initiated, prospective, observational, two arm, randomized study to
be performed at up to four experienced 'Radial First' centers (UCSD, UCLA. Arkansas Heart
Hospital and LBVA). A maximum of 180 patients having undergone successful radial
catheterization will be enrolled in the study, 60 in each arm. 60 patients will be enrolled
at the LBVA. Enrollment will continue at each site on discretion of the investigators until
each center enrolls a minimum of 30 patients, or a maximum of 180 patients are enrolled.
Clinicians will perform the catheterization in accordance with local standard practice, with
a minimum of 5,000 units of unfractionated heparin for anticoagulation. At the start of the
TRA procedure, prior to radial artery cannulation, a baseline Pleth-ox exam will be performed
for all patients and recorded on the CRF. Ulnar compression will be applied to confirm that
the radial artery is patent. Patients with a type D pattern exam will be excluded from the
study. At the conclusion of a successful transradial procedure, the patient will be
randomized to either SSA or TRB, each device applied per protocol & IFU. It is hypothesized
that if radial artery compression time can be shortened to 40 minutes or less, the following
could result: improved catheterization lab efficiency, greater patient satisfaction and lower
complication rates, including RAO, may be improved.

Inclusion Criteria:

- Patient undergoing diagnostic angiography or PCI via the radial artery

- Patients with a Barbeau test prior to the procedure showing pattern A,B,or

Exclusion Criteria:

- Use of a radial sheath larger than 6 Fr (a 7Fr-in-6 Glidesheath Slender ® is allowed).

- Use of an anticoagulant other than unfractionated heparin or bivalirudin.

- Any anticipated need for continued anticoagulation post-catheterization. Glycoprotein
inhibitors are acceptable.

- Any active treatment with oral anticoagulants continued during course of procedure.

- Presence of arteriovenous dialysis fistula in the ipsilateral arm.

- Any physical deformity or trauma / injury of either wrist that would prevent proper
placement or function of the hemostasis band.

- Raynaud's syndrome or known peripheral vascular disease of the forearm.

- Mental incompetence or inability to follow the instructions to complete the study.

- History or presence of Radial Artery Occlusion.

- Barbeau test showing Pattern D.

- Patients undergoing catheterization from the femoral or ulnar artery approach.

- Cardiogenic shock or any clinical instability as assessed by the physician performing
the procedure.