Clinical Trials Logo
NCT number NCT03292367
Study type Observational
Source Wonju Severance Christian Hospital
Contact Seung-Hwan Lee, MD, PhD
Phone +82-33-741-0920
Status Recruiting
Phase N/A
Start date October 11, 2017
Completion date July 1, 2018

Clinical Trial Summary

Left distal transradial approach (ldTRA) can be an attractive alternative route for left radial and right radial artery. Recently, Ferdinand Kiemeneij reported the feasibility and safety of the use of ldTRA. But, there is few studies focused on this issue. Therefore, the purpose of this prospective observational study is to assess the feasibility and safety of the ldTRA for CAG and PCI.

Clinical Trial Description

Femoral artery has been traditionally used as a standard route for coronary angiography (CAG) and percutaneous coronary intervention (PCI). Recently, the frequency of use of transradial approach (TRA) is increasing. TRA has several advantages in terms of more comfortable feeling, immediate ambulation, less bleeding complication and decreased mortality rate compared to transfemoral approach (TFA). 2015 ESC guidelines recommend to use of radial artery in order to reduce bleeding complication and mortality. But, most operators tend to prefer right radial approach (RRA) for the access route, because they are usually right-handed and feel more comfortable in the use of right radial artery. Particularly when the patient is obese or the operator's height is short or has a herniated disc on neck or waist, the discomfort may become greater.

In other hand, left radial approach (LRA) have several advantages. Left brachial artery or subclavian artery is less tortuous than right side. The manipulation of catheter is similar with femoral approach. Also, since most patients are right-handed, compression after LRA leads to greater comfort for the patient.

In comparison to the convenience of the patient and procedure, comparative studies on clinical outcomes showed similar results for both RRA and LRA. But LRA may be more at risk for radiation. This is because the operator has to lean more toward the patient for the procedure, which can result in increased radiation exposure.

Recently, the left distal radial artery approach (ldTRA) has been introduced as an alternative to feasibility and safety while satisfying both patient and operator convenience. The left palm is positioned facing the floor at the left groin. Left distal radial artery is punctured at the level of anatomical snuffbox. Ferdinand Kiemeneij reported that CAG and PCI were successfully performed in 70 patients.

There are no nerve and vein in the anatomical snuffbox. And distal radial artery is located at superficial area. So, there may be potential advantage to reduce bleeding complication and nerve injury. Moreover, ldTRA can be an alternative method for the patient requiring arteriovenous fistula and for the patient preparing coronary artery bypass graft because there is no injury of left radial artery.

The patients have potential bleeding risk because dual antiplatelet agents (aspirin 300mg and clopidogrel 300mg) and more than 3,000 units of unfractionated heparin should be loaded for CAG and PCI. The effective hemostasis method has not yet been established after ldTRA. Therefore, it is important to establish effective hemostasis method and timing. However, like TRA, ldTRA requires a learning curve to be mastered, and it cannot be performed if the pulse is not palpable. There are few studies related to ldTRA. The purpose of this prospective observational study is to assess the feasibility and safety of the ldTRA for CAG and PCI.

Study Design

Related Conditions & MeSH terms

See also
  Status Clinical Trial Phase
Not yet recruiting NCT03259815 - How Often Can Optimal Post Percutaneous Coronary Intervention (PCI) Fractional Flow Reserve (FFR) Results be Achieved? N/A
Recruiting NCT03216720 - Miniaturized Extracorporeal Circulation Study N/A
Completed NCT01930214 - Multi-center Prospective Study to Evaluate Outcomes of the Moderate to Severely Calcified Coronary Lesions (MACE) N/A
Recruiting NCT03198806 - Water Intake Associated With Aerobic Exercise in Coronary N/A
Recruiting NCT03265535 - Validation of a Single Rest-Stress Imaging Protocol for Myocardial Perfusion Imaging N/A
Not yet recruiting NCT03284229 - Multicenter Study to Evaluate the Procedural Safety and Efficacy of ELCA in CAD N/A
Not yet recruiting NCT02252783 - BFPET for Regional Myocardial Perfusion Imaging Phase 2
Not yet recruiting NCT03231527 - Outcomes of Total Arterial Coronary Artery Bypass Grafting N/A
Not yet recruiting NCT03252990 - 18F-fluorocholine PET-MR Imaging of Coronary Plaque Vulnerability N/A
Not yet recruiting NCT03265041 - Long Term Predictors of Graft Patency After Coronary Artery Bypass Graft Surgery (Multi-slice CT Coronary Angiography Study Validated by Coronary Angiography) N/A
Recruiting NCT02832115 - Topical Nitroglycerine Treatment for Radial Artery Spasm Prevention Phase 4
Recruiting NCT02814578 - Assessment of Coronary Artery Lesion Using Optical Coherence Tomography Versus IntraVascular Ultrasound for BiorEsorbable Vascular Scaffold Implantation N/A
Recruiting NCT02693158 - The Direct III Post Market Study N/A
Recruiting NCT03027856 - The BIFSORB Pilot Study II N/A
Recruiting NCT02922088 - EU Multicenter Registry to Assess Outcomes in CABG Patients: Treatment of Vascular Conduits With DuraGraft [VASC] N/A
Recruiting NCT02939729 - Physiotherapy Prehabilitation in Patients Undergoing Cardiac or Thoracic Surgery N/A
Enrolling by invitation NCT02894255 - Prospective Multicenter Registry of Hybrid Coronary Artery Revascularization Combined With Surgical Bypass and Percutaneous Coronary Intervention Using Everolimus Eluting Metallic Stents Phase 4
Enrolling by invitation NCT02806479 - Hypertrophic Cardiomyopathy Pilot Study N/A
Not yet recruiting NCT02871622 - BMX Alpha Registry: a Post-market Registry of the BioMatrix Alpha TM N/A
Not yet recruiting NCT02863939 - Quantitation of Cardiac Output Change by Impedance Cardiography in Subjects Undergoing Exercise Gated Stress/Rest Tc-99m CZT-SPECT MPI N/A