Radial Artery OcclusionNCT04933136
Radial Artery Occlusion and Dual Artery Hemostasis After Transradial Approach.
An observational study of Radial Artery Occlusion, run by Laval University at 5 sites in Canada.
Trial summary
Improving patient comfort and implementing the protocols required to minimize the risk of RAO must be part of quality control. Several procedural parameters are related to the risk of RAO but hemostasis is a critical period. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radial Artery Occlusion
- What is being tested?
- Terry2 Band
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 5 sitesCanada
- Study dates
- 12 Dec 2022to 31 Dec 2025
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: All comer adult population referred for diagnostic or interventional catheterization by transradial or transcubital approach at the participant centers.
Who may be able to join
- Any patient referred for diagnostic or interventional catheterization through radial or cubital approach
Who cannot join
- Unable to understand the study design and sign an informed consent
- Unable to receive antiplatelet therapy with aspirin and/or clopidogrel-prasugrel and/or ticagrelor and intravenous anticoagulant treatment with heparin or bivalirudin
- Presence of any local conditions like hematoma or pseudo-aneurysms precluding radial or cubital access.
- Presence of PPG while simultaneously compressing the radial and cubital arteries (due to collateral branches or interosseous artery), which prevents the establishment of non-occlusive hemostasis with the Terry2(TM) band.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Michèle Jadin contact
5 sites in 1 country
Canada5 sites, 5 recruiting
- Not yet recruiting
CSSS Chicoutimi
Chicoutimi, Quebec, G7H 5H6
Francis Bonenfant
Francis Bonenfant, MD
- Not yet recruiting
CHUM- Centre hospitalier de l'Université de Montréal
Montreal, Quebec
Samer Mansour
Adriana Carbonaro
- Not yet recruiting
CHU de Québec
Québec, Quebec
Jimmy MacHaalany
- Recruiting
IUCPQ - Laval Hospital
Québec, Quebec
Tomas A Cieza Lara, MD
Tomas A. Cieza Lara, MD
- Not yet recruiting
Hôpital Sainte-Marie
Trois-Rivières, Quebec
Vincent Spagnoli, MD
About this study
Official title: A Prospective Registry for the Evaluation of the Safety, Efficacy and Clinical Impact of the Double Hemostasis System Terry2 (TM) on Patients Undergoing a Trans-radial or Trans-cubital Catheterism.
- Improving patient comfort and implementing the protocols required to minimize the risk of RAO must be part of quality control.
- Several procedural parameters are related to the risk of RAO but hemostasis is a critical period.
- Despite the fact that non-occlusive hemostasis of the radial artery is a recognized and effective technique for reducing the risk of RAO, it is rarely practiced because it is tedious, involves additional care and is not always effective with current hemostasis systems.
- Prophylactic compression of the cubital artery during radial artery hemostasis has been shown to be effective in maintaining non-occlusive hemostasis but requires 2 devices and does not simplify care procedures.
- The Terry2™ band is a new dual device that offers effortless non-occlusive radial hemostasis and does not require repeated intervention by nursing staff.
The primary objectives of this observational study are to demonstrate the benefits, safety and impact on care of using Terry2™ band in patients undergoing diagnostic or interventional catheterization by radial (or ulnar) approach.
Read the detailed description
Radial Artery Occlusion (RAO) is the most common peri-procedural complication after a trans-radial catheterization,
Although usually asymptomatic, RAO may prevent the use of radial artery access in future catheterization should the patient need one; the use And the artery cannot be used as an alternate graft in case the patient is referred for aorto-coronary bypass surgery.
Recent data has demonstrated a clinical benefit for the use of radial artery over a venous graft for patients requiring artery bypass grafts.
Current international recommendations suggest limiting the risk of RAO to less than 5% upon discharge from hospital. To do this a change of method, ie performing a non-occlusive hemostasis of the radial artery is the most effective method to limit the risk of RAO. Unfortunately, this method takes time and requires repeated interventions by nurses, which has limited its application worldwide. In addition, simple hemostasis systems (on radial artery alone) can only achieve non-occlusive hemostasis in 60-75% of cases.
On the other hand, it has been shown that by applying simultaneous pressure to the two arteries of the wrist (the radial artery and the cubital artery), one could obtain a non-occlusive hemostasis of the radial artery in more than 95% of cases and the level of RAO was reduced < 2%. However, the handling of 2 separate hemostasis systems again requires repeated intervention by the nursing staff and therefore burdens the monitoring procedure.
The device Terry2™ band applies simultaneous differential compression to the radial artery and the cubital artery. Its mechanism of action aims to accelerate the time of hemostasis, reduce nursing work, improve patient comfort and minimize the risk of radial artery occlusion during and after hemostasis.
Hypotheses:
- The Terry2™ band provides fast and safe non-occlusive radial hemostasis that limits the risk of RAO.
- The Terry2™ band is associated with increased patient comfort, reduced staff work and a minimized risk of RAO after radial catheterization.
Procedures:
At the end of the radial approach procedure, patients will have a Terry2 band installed™ according to the instructions for use. Staff will be trained on the use of the device by means of an educational video. Once the device is installed, a check for the presence of non-occlusive hemostasis will be done before the patient has returned to their room.
Once the hemostasis is completed, the permeability of the radial artery is again checked by pulse oximetry. In case of doubt about the permeability of the instrumented artery, it is recommended to validate with an ultrasound-doppler.
Rates of RAO and other access site complications, total nursing time involved and patient comfort will be evaluated.
- Conditions
- Radial Artery Occlusion
- Being tested
- Terry2 Band
- Keywords
- Radial Artery Occlusion, Transradial approach, Transulnar approach, Dual artery hemostasis, Patent hemostasis
- 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.
Terry2 BandDevice
Hemostasis protocol following radial or cubital approach catheterization using the dual artery hemostasis device Terry2Band.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of radial artery occlusion
Rate of radial artery occlusion throughout hemostasis until hospital discharge as measured by oximetry (photoplethysmography PPG) .
The absence of a PPG curve indicates radial artery occlusion. Inconclusive cases maybe confirmed by doppler echography.
Measured: 30 - 270 minutes after catheterization
Total time to hemostasis
Characterization of the total time required to obtain hemostasis of the access site after transradial catheterization using the Terry2 band.
Measured from device installation until removal.
Measured: 30 - 270 minutes after catheterization or until hemostasis is achieved
Secondary outcomes (3)
Change in patient comfort rating
Change on patient comfort/pain perception measured by a visual analog scale (VAS) before placing the device and after its removal.
The VAS used ranges from 0 to 10, where the lower scores refer to lower pain and higher comfort.
0 -1 Very comfortable / No pain 2 -3 Comfortable / Mild pain 4 - 5 Somewhat comfortable / Moderate Pain 6 - 7 Somewhat uncomfortable / Severe Pain 8 - 9 Uncomfortable / Very severe pain 10- Very uncomfortable / Extreme pain
Measured: During procedure
Rate of access site complications
Using the EASY scale for hematoma and bleeding
Measured: up to 30 days after catheterization
Total nursing time involvement
Total nursing time dedicated to care for access site until hemostasis is achieved. Calculated as as a combination of the number of interventions and time per intervention.
Measured: During hemostasis up to 24 hours after catheterization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start12 Dec 2022
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radial Artery OcclusionStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomas Cieza Lara, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04933136
- Sponsor's protocol ID
- Registry-Terry2 Band
- Status last verified
- Mar 2025
- First submitted
- 12 Jun 2021
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Registry for the Evaluation of the Safety, Efficacy and Clinical Impact of the Double Hemostasis System Terry2 (TM) on Patients Undergoing a Trans-radial or Trans-cubital Catheterism.
- ClinicalTrials.gov ID
- NCT04933136
- Acronym / sponsor ID
- Registry-Terry2 Band
- Conditions
- Radial Artery Occlusion
- Keywords
- Radial Artery Occlusion, Transradial approach, Transulnar approach, Dual artery hemostasis, Patent hemostasis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 12 Dec 2022 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 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.
- Improving patient comfort and implementing the protocols required to minimize the risk of RAO must be part of quality control.
- Several procedural parameters are related to the risk of RAO but hemostasis is a critical period.
- Despite the fact that non-occlusive hemostasis of the radial artery is a recognized and effective technique for reducing the risk of RAO, it is rarely practiced because it is tedious, involves additional care and is not always effective with current hemostasis systems.
- Prophylactic compression of the cubital artery during radial artery hemostasis has been shown to be effective in maintaining non-occlusive hemostasis but requires 2 devices and does not simplify care procedures.
- The Terry2™ band is a new dual device that offers effortless non-occlusive radial hemostasis and does not require repeated intervention by nursing staff.
The primary objectives of this observational study are to demonstrate the benefits, safety and impact on care of using Terry2™ band in patients undergoing diagnostic or interventional catheterization by radial (or ulnar) approach.
Detailed description
Radial Artery Occlusion (RAO) is the most common peri-procedural complication after a trans-radial catheterization,
Although usually asymptomatic, RAO may prevent the use of radial artery access in future catheterization should the patient need one; the use And the artery cannot be used as an alternate graft in case the patient is referred for aorto-coronary bypass surgery.
Recent data has demonstrated a clinical benefit for the use of radial artery over a venous graft for patients requiring artery bypass grafts.
Current international recommendations suggest limiting the risk of RAO to less than 5% upon discharge from hospital. To do this a change of method, ie performing a non-occlusive hemostasis of the radial artery is the most effective method to limit the risk of RAO. Unfortunately, this method takes time and requires repeated interventions by nurses, which has limited its application worldwide. In addition, simple hemostasis systems (on radial artery alone) can only achieve non-occlusive hemostasis in 60-75% of cases.
On the other hand, it has been shown that by applying simultaneous pressure to the two arteries of the wrist (the radial artery and the cubital artery), one could obtain a non-occlusive hemostasis of the radial artery in more than 95% of cases and the level of RAO was reduced < 2%. However, the handling of 2 separate hemostasis systems again requires repeated intervention by the nursing staff and therefore burdens the monitoring procedure.
The device Terry2™ band applies simultaneous differential compression to the radial artery and the cubital artery. Its mechanism of action aims to accelerate the time of hemostasis, reduce nursing work, improve patient comfort and minimize the risk of radial artery occlusion during and after hemostasis.
Hypotheses:
- The Terry2™ band provides fast and safe non-occlusive radial hemostasis that limits the risk of RAO.
- The Terry2™ band is associated with increased patient comfort, reduced staff work and a minimized risk of RAO after radial catheterization.
Procedures:
At the end of the radial approach procedure, patients will have a Terry2 band installed™ according to the instructions for use. Staff will be trained on the use of the device by means of an educational video. Once the device is installed, a check for the presence of non-occlusive hemostasis will be done before the patient has returned to their room.
Once the hemostasis is completed, the permeability of the radial artery is again checked by pulse oximetry. In case of doubt about the permeability of the instrumented artery, it is recommended to validate with an ultrasound-doppler.
Rates of RAO and other access site complications, total nursing time involved and patient comfort will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All comer adult population referred for diagnostic or interventional catheterization by transradial or transcubital approach at the participant centers.
Key inclusion criteria (1 listed)
- Any patient referred for diagnostic or interventional catheterization through radial or cubital approach
Key exclusion criteria (4 listed)
- Unable to understand the study design and sign an informed consent
- Unable to receive antiplatelet therapy with aspirin and/or clopidogrel-prasugrel and/or ticagrelor and intravenous anticoagulant treatment with heparin or bivalirudin
- Presence of any local conditions like hematoma or pseudo-aneurysms precluding radial or cubital access.
- Presence of PPG while simultaneously compressing the radial and cubital arteries (due to collateral branches or interosseous artery), which prevents the establishment of non-occlusive hemostasis with the Terry2(TM) band.
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 |
|---|---|---|
| Terry2 BandHemostasis protocol following radial or cubital approach catheterization using the dual artery hemostasis device Terry2Band. | Device | – |
Primary outcome
Rate of radial artery occlusion
Time frame: 30 - 270 minutes after catheterization
Rate of radial artery occlusion throughout hemostasis until hospital discharge as measured by oximetry (photoplethysmography PPG) . The absence of a PPG curve indicates radial artery occlusion. Inconclusive cases maybe confirmed by doppler echography.
Total time to hemostasis
Time frame: 30 - 270 minutes after catheterization or until hemostasis is achieved
Characterization of the total time required to obtain hemostasis of the access site after transradial catheterization using the Terry2 band. Measured from device installation until removal.
3 secondary outcomes
Change in patient comfort rating
Time frame: During procedure
Rate of access site complications
Time frame: up to 30 days after catheterization
Total nursing time involvement
Time frame: During hemostasis up to 24 hours after catheterization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
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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.
Michèle Jadin contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radial Artery Occlusion, run by Laval University at 5 sites in Canada.
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 1 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tomas A Cieza Lara, MD (+1 481 6568711 ext. 4666, tomas.cieza@criucpq.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of radial artery occlusion (time frame: 30 - 270 minutes after catheterization). The study lists 2 primary outcomes in all. 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 10 Mar 2025.