Clinical trial NCT03028025: Comparing TR Band to Statseal in Conjunction With TR Band
Official title: Radial Hemostasis is Facilitated With a Potassium Ferrate Hemostatic Patch (Statseal): the Randomized Controlled Statseal With TR Band Assessment Trial (STAT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterial Occlusion
Angina Pectoris
Cardiovascular Diseases
Atherosclerosis
Hematoma
Anticoagulant-Induced Bleeding
Coronary Artery Disease
Keywords: radial artery occlusion
time to hemostasis
radial artery
transradial catheterization
TR band
Statseal
hemostasis band
potassium ferrate
percutaneous coronary intervention
Lead sponsor: VA Long Beach Healthcare System
Sponsor class: FED
First posted: 2017-01-23
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary objectives of this study are to evaluate the performance of StatSeal Advanced used in conjunction with the TR Band (SSA) as compared to the TR Band without SSA (TRB) relative to: the incidence of peri-procedural radial artery occlusion (RAO) at discharge or 24 hours, whichever occurs first, and the Time to Hemostasis (TTH).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to Hemostasis Using the Hemostasis Management System (HMS)
timeFrame: within 30 min of discharge or after 24 hours
Secondary outcomes:
measure: Percent of Patients With Radial Artery Occlusion(RAO)
timeFrame: within 30 min of discharge or after 24 hours
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Veteran Affairs Long Beach
state: California
Study officials:
affiliation: VA Long Beach Hospital
name: Arnold H Seto, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seto AH, Rollefson W, Patel MP, Suh WM, Tehrani DM, Nguyen JA, Amador DG, Behnamfar O, Garg V, Cohen MG. Radial haemostasis is facilitated with a potassium ferrate haemostatic patch: the Statseal with TR Band assessment trial (STAT). EuroIntervention. 2018 Dec 7;14(11):e1236-e1242. doi: 10.4244/EIJ-D-18-00101.