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Completed

NCT Number: NCT04911218

GlideSheath Slender® Versus Conventional 5Fr Arterial Sheath in Coronary Angiography Through the Distal Radial Artery

Transradial approach has become the default arterial access for coronary angiography (CAG) and percutaneous coronary intervention (PCI), mainly due to lower incidence of bleeding compared to transfemoral access.1 However, TRA is not deprived of local access site complications such as radial artery occlusion (RAO), occurring in approximately 5.2% of patients, compartment syndrome, pseudoaneurysm, hematoma, and arteriovenous fistula. Recently, a novel approach has been proposed, the access through the distal radial artery (distal transradial access, dTRA), located in the anatomical snuffbox. Initial studies regarding the dRA have shown feasibility and benefits, including shorter hemostasis time, fewer local access site complications and potentially lower incidence of RAO.

GlideSheath Slender is a novel sheath which has a hydrophilic coating and is made of a thinner material than traditional sheaths. As a result, the external diameter of the 5 Fr GlideSheath Slender sheath is 1 Fr lower compared with conventional arterial sheaths.

The purpose of the present study was to investigate whether the use of the Slender sheath affects the time of hemostasis, sheath insertion time, crossover rate to conventional radial access, pain associated with the procedure and incidence of local access site complications (RAO, distal radial artery occlusion, fistula, hematoma) in patients undergoing diagnostic angiography through the distal radial artery.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Patras

Pátrai, Achaia, 26504, Greece

About this study

Patients fulfilling the enrollment criteria will be randomized 1:1 to GlideSheath Slender versus conventional 5Fr arterial sheath for access through the distal radial artery (dTRA). In case an interventional procedure is required then the initial sheath will be exchanged to a larger sheath according to the circumstances of the case and the patient will not be included in the analysis.

For randomized patients sheath insertion time, necessity for crossover to conventional radial access, pain associated with the procedure (visual pain scale) and occurrence of hematoma will be recorded. Follow-up ultrasound 7-10 days after the procedure for detection of RAO, distal radial artery occlusion and fistula formation will be performed.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Indication for coronary angiography
  • Age>18 years
  • Informed consent

Exclusion criteria

  • Non-palpable right radial artery
  • Prior CABG
  • STEMI
  • Prior right transaradial intervention within the previous 2 months
  • Hemodynamic instability
  • Anatomical restrictions (fistula orthopaedic problems, etc)

Treatment and study plan

GlideSheath Slender 5Fr arterial sheath

Device

Placement of GlideSheath Slender 5Fr arterial sheath for coronary angiography through the distal radial artery (anatomical snuffbox).

Conventional 5Fr arterial sheath

Device

Placement of conventional 5Fr arterial sheath for coronary angiography through the distal radial artery (anatomical snuffbox).

Primary outcomes

  1. Rate of successful hemostasis at 30 minutes after sheath removal

    Time frame: At 30 minutes after sheath removal

Secondary outcomes

  1. Crossover rate to conventional radial access

    Time frame: During the procedure

  2. Pain associated with the procedure (visual analog scale, VAS)

    Time frame: During the procedure

    0-10, 0: no pain, 10: worst pain possible

  3. Rate of hematoma modified EASY class≥II

    Time frame: Up to 24 hours after hemostatic device removal

  4. Rate of forearm radial artery occlusion

    Time frame: 7-10 days after the coronary angiography

  5. Rate of distal radial artery occlusion

    Time frame: 7-10 days after the coronary angiography

  6. Rate of fistula formation

    Time frame: 7-10 days after the coronary angiography

  7. Rate of pseudoaneurysm formation

    Time frame: 7-10 days after the coronary angiography

Sponsors and collaborators

Lead sponsor

University Hospital of Patras

Other

Registry information

Official study title

Randomized Comparison of GlideSheath Slender® Versus Conventional 5Fr Arterial Sheath in Coronary Angiography Through the Distal Radial Artery (Anatomical Snuffbox)

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 2, 2021
Registry last updated
Dec 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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