N/A
Completed N=184
Comparing TR Band to Statseal in Conjunction With TR Band
Arterial Occlusion · Angina Pectoris · Cardiovascular Disease · Atherosclerosis
Source: ClinicalTrials.gov NCT03028025 ↗
Enrolled (actual)
184
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcomePrimary: Time to Hemostasis Using the Hemostasis Management System (HMS) — 160; 42.95 minutes
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Hemostasis Using the Hemostasis Management System (HMS) |
160; 42.95 | — |
| SECONDARY Percent of Patients With Radial Artery Occlusion(RAO) |
0; 2 | — |
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.
Data sourced from ClinicalTrials.gov (NCT03028025). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.