Arterial AccessNCT04911218
GlideSheath Slender® Versus Conventional 5Fr Arterial Sheath in Coronary Angiography Through the Distal Radial Artery
A study testing GlideSheath Slender 5Fr arterial sheath and Conventional 5Fr arterial sheath in people with Arterial Access and Coronary Angiography, run by University Hospital of Patras at 1 site in Greece.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arterial Access, Coronary Angiography, Radial Artery Occlusion
- What is being tested?
- GlideSheath Slender 5Fr arterial sheath and Conventional 5Fr arterial sheath
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 371 participants
- Where
- 1 siteGreece
- Study dates
- 10 May 2021to 2 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for coronary angiography
- Age>18 years
- Informed consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Comparison of GlideSheath Slender® Versus Conventional 5Fr Arterial Sheath in Coronary Angiography Through the Distal Radial Artery (Anatomical Snuffbox)
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.
Read the detailed description
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.
- Being tested
- GlideSheath Slender 5Fr arterial sheath, Conventional 5Fr arterial sheath
- Keywords
- arterial access, coronary angiography, radial access, distal radial access, radial artery occlusion
- Medical subject headings
- Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlideSheath Slender 5Fr arterial sheathDevice
Placement of GlideSheath Slender 5Fr arterial sheath for coronary angiography through the distal radial artery (anatomical snuffbox).
Conventional 5Fr arterial sheathDevice
Placement of conventional 5Fr arterial sheath for coronary angiography through the distal radial artery (anatomical snuffbox).
| Study group | Role | What they receive |
|---|---|---|
| GlideSheath Slender 5Fr arterial sheath | Experimental | Placement of GlideSheath Slender 5Fr arterial sheath for diagnostic angiography through the distal radial artery (anatomical snuffbox). Receives: Device: GlideSheath Slender 5Fr arterial sheath |
| Conventional 5Fr arterial sheath | Active comparator | Placement of Conventional 5Fr arterial sheath arterial sheath for diagnostic angiography through the distal radial artery (anatomical snuffbox). Receives: Device: Conventional 5Fr arterial sheath |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of successful hemostasis at 30 minutes after sheath removal
Measured: At 30 minutes after sheath removal
Secondary outcomes (7)
Crossover rate to conventional radial access
Measured: During the procedure
Pain associated with the procedure (visual analog scale, VAS)
0-10, 0: no pain, 10: worst pain possible
Measured: During the procedure
Rate of hematoma modified EASY class≥II
Measured: Up to 24 hours after hemostatic device removal
Rate of forearm radial artery occlusion
Measured: 7-10 days after the coronary angiography
Rate of distal radial artery occlusion
Measured: 7-10 days after the coronary angiography
Rate of fistula formation
Measured: 7-10 days after the coronary angiography
Rate of pseudoaneurysm formation
Measured: 7-10 days after the coronary angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start10 May 2021
- Primary completion25 Nov 2021
- Study completion2 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arterial AccessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 371 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grigorios Tsigkas, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911218
- Sponsor's protocol ID
- 1762/22.01.21
- Status last verified
- Dec 2021
- First submitted
- 20 May 2021
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of GlideSheath Slender® Versus Conventional 5Fr Arterial Sheath in Coronary Angiography Through the Distal Radial Artery (Anatomical Snuffbox)
- ClinicalTrials.gov ID
- NCT04911218
- Acronym / sponsor ID
- 1762/22.01.21
- Keywords
- arterial access, coronary angiography, radial access, distal radial access, radial artery occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 371 participants (actual)
- Lead sponsor
- University Hospital of PatrasUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 25 Nov 2021 (actual)
- Study completion
- 2 Dec 2021 (actual)
- First posted
- 2 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GlideSheath Slender 5Fr arterial sheath | Experimental | Device: GlideSheath Slender 5Fr arterial sheathPlacement of GlideSheath Slender 5Fr arterial sheath for diagnostic angiography through the distal radial artery (anatomical snuffbox). |
| Conventional 5Fr arterial sheath | Active comparator | Device: Conventional 5Fr arterial sheathPlacement of Conventional 5Fr arterial sheath arterial sheath for diagnostic angiography through the distal radial artery (anatomical snuffbox). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Indication for coronary angiography
- Age>18 years
- Informed consent
Key exclusion criteria (6 listed)
- Non-palpable right radial artery
- Prior CABG
- STEMI
- Prior right transaradial intervention within the previous 2 months
- Hemodynamic instability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlideSheath Slender 5Fr arterial sheathPlacement of GlideSheath Slender 5Fr arterial sheath for coronary angiography through the distal radial artery (anatomical snuffbox). | Device | GlideSheath Slender 5Fr arterial sheath |
| Conventional 5Fr arterial sheathPlacement of conventional 5Fr arterial sheath for coronary angiography through the distal radial artery (anatomical snuffbox). | Device | Conventional 5Fr arterial sheath |
Primary outcome
Rate of successful hemostasis at 30 minutes after sheath removal
Time frame: At 30 minutes after sheath removal
7 secondary outcomes
Crossover rate to conventional radial access
Time frame: During the procedure
Pain associated with the procedure (visual analog scale, VAS)
Time frame: During the procedure
Rate of hematoma modified EASY class≥II
Time frame: Up to 24 hours after hemostatic device removal
Rate of forearm radial artery occlusion
Time frame: 7-10 days after the coronary angiography
Rate of distal radial artery occlusion
Time frame: 7-10 days after the coronary angiography
Rate of fistula formation
Time frame: 7-10 days after the coronary angiography
Rate of pseudoaneurysm formation
Time frame: 7-10 days after the coronary angiography
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GlideSheath Slender 5Fr arterial sheath and Conventional 5Fr arterial sheath in people with Arterial Access and Coronary Angiography, run by University Hospital of Patras at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of successful hemostasis at 30 minutes after sheath removal (time frame: At 30 minutes after sheath removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.