Coronary InterventionHEMOSTAD-INCNCT05966376
Efficacy and Safety of Hemostatic Methods in Distal Radial Artery Approach for Cardiac Catheterization
A study testing Hemostatic device for distal radial approach. in people with Coronary Intervention and Transradial Approach, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
Trial summary
Comparison of PreludeSYNC distal and Modified Terumo Radial Band in patients with distal radial approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Intervention, Transradial Approach
- What is being tested?
- Hemostatic device for distal radial approach.
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 482 participants
- Where
- 1 siteMexico
- Study dates
- 1 Feb 2022to 1 Dec 2023
- 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
- Coronary artery disease including chronic coronary syndrome or acute coronary syndrome.
- Cardiovascular disease that requires coronary angiography in its approach.
Who cannot join
- Cardiogenic shock.
- Lesions in venous or arterial hemoducts.
- Impossibility to provide informed consent.
- Chronic kidney disease on hemodialysis through arteriovenous fistula at the same site where the approach is planned.
- Severe chronic renal failure (GFR less than 30 ml/min/m2)
- Patients diagnosed with cancer.
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- Patient with rheumatological and hematological pro-thrombotic disorders.
- Non-hydrophilic radial introducer.
- Failed cannulation of the radial artery with an introducer.
- Successful trans-radial access that is crossed over to the femoral approach.
- Patients with an interventional procedure using a radial approach in the previous 30 days.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Cardiologia Ignacio Chávez
Mexico City, 14080
About this study
Comparison of PreludeSYNC distal and Modified Terumo Radial Band in patients with distal radial approach.
Read the detailed description
INTRODUCTION AND BACKGROUND
Distal radial access at the level of the anatomical snuffbox and dorsal region of the hand has currently positioned itself as a viable and safe approach for procedures in interventional cardiology, whether diagnostic, simple, or complex angioplasties. We know that this approach method mainly reduces the occlusion rate of the proximal radial artery, among other advantages; however, we still do not have scientific evidence on the various hemostasis methods for this approach. Practice varies between centers and countries and hemostasis methods vary from an elastic compression bandage to the use of devices manufactured specifically for this approach such as the PreludeSYNC DISTAL or modification of devices manufactured for proximal radial hemostasis such as the TR band. In this clinical trial, we intend to analyze the efficacy and safety of two hemostasis methods in patients who require an interventional procedure (PredludeSYNC DISTAL vs modified TR band), to date, there is no clinical trial that compares these methods face to-face in relation to their efficacy and safety. Retrospective studies indicate that both methods are effective in reducing radial artery occlusion and are safe in reducing the bleeding/hematoma rate.
THE PURPOSE OF THE STUDY To compare the efficacy (distal radial artery occlusion) and safety (hematoma/bleeding) of two devices of distal radial hemostasis (PreludeSYNC distal and TR band) in patients undergoing percutaneous coronary intervention.
STUDY DESIGN Experimental, randomized, prospective, longitudinal, prolective, and comparative.
SUBJECTS OF STUDY Patients from the Ignacio Chávez National Institute of Cardiology who will undergo distal radial percutaneous coronary intervention/angiography.
METHODOLOGY After signing the informed consent, patients will be randomized by balanced block methods to: 1) Hemostasis using the PreludeSYNC distal device, or 2) Hemostasis using the Modified Radial Band device.
PRIMARY OUTCOME To compare the efficacy (distal radial artery occlusion) and safety (hematoma/bleeding) of PreludeSYNC distal versus Modified Terumo Radial Band in distal radial approach.
- Conditions
- Coronary Intervention, Transradial Approach
- Being tested
- Hemostatic device for distal radial approach.
- Keywords
- Distal Radial Artery Access, PreludeSYNC distal, Terumo Radial Band
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemostatic device for distal radial approach.Device
Also called PreludeSYNC distal, Terumo Radial Band
Hemostasis after distal radial approach is done with one of two devices, one of them is designed specifically for the distal radial approach; the other is not but a modified technique with the last one could be helpful.
| Study group | Role | What they receive |
|---|---|---|
| Modified Terumo Radial Band | Experimental | A standard hemostatic device used for proximal radial approach. The hard plastic component is removed to achieve better attachment in the distal radial approach.
* Clean and dry the puncture site.
* The introducer is withdrawn 2 cm.
* Place the device on the patient's hand depending on the approach side.
* Terumo logo is positioned toward the little finger side.
* The green mark is positioned 1 cm proximal to the puncture site.
* The bands are adjusted and fixed around the wrist.
* The Terumo syringe is filled with 15 ml of air.
* The balloon of the device is slowly inflated through the valve while the introducer is slowly withdrawn simultaneously.
* Once the introducer is completely withdrawn, the balloon continues to be inflated until the absence of bleeding is verified.
* Once hemostasis is achieved, the patient must be able to move his fingers and wrist without bleeding. If bleeding is observed, the balloon is inflated to achieve adequate hemostasis. Receives: Device: Hemostatic device for distal radial approach. |
| PreludeSYNC distal | Active comparator | A specific hemostatic device, designed for distal radial approach.
* Clean and dry the puncture site.
* Selection and preparation of the PreludeSYNC distal device according to the approach side.
* The introducer is withdrawn 2cm.
* The hemostasis device is placed on the patient's hand.
* Bands position: 1) little finger side; 2) thumb side; 3) between the thumb and the index finger.
* The circular mark of the balloon is positioned 1cm proximal to the puncture site.
* Bands are adjusted and fixed.
* The syringe is filled with 10 ml of air.
* The balloon of the device is slowly inflated while the introducer is slowly withdrawn simultaneously.
* Once the introducer is completely withdrawn, the balloon continues to be inflated until the absence of bleeding is verified.
* Once hemostasis is achieved, the patient must be able to move his fingers and wrist without bleeding. If bleeding is observed, the balloon should be inflated to achieve adequate hemostasis. Receives: Device: Hemostatic device for distal radial approach. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the incidence of proximal radial artery occlusion assessed by ultrasound and the incidence of hematoma/bleeding assessed clinically by EASY scale of PreludeSYNC distal versus Modified Terumo Radial Band in distal radial approach.
At 24 hours after the procedure, patients will be evaluated by interrogation, physical exam and ultrasonography. The absence of Doppler flow in the proximal radial artery at wrist level will define the occlusion of the radial artery. The EASY scale will be used to classify the severity of the hematoma in degrees from I to V according to the extension.
Measured: 24 hours after the procedure. Patients with radial occlusion at 24 hours will be follow at 30 days.
Secondary outcomes (6)
Incidence of distal and proximal radial artery occlusion at 24 hours after the procedure.
Evaluated by clinical signs and doppler.
Measured: 24 hours after the procedure.
Radial arterial patency at 30 days in patients with obstruction at 24 hours.
Evaluated by clinical signs and ultrasound doppler.
Measured: 30 days after the procedure
Incidence of hematoma at the approach site.
Evaluated by clinical signs. Classified according to EASY scale.
Measured: 24 hours after the procedure.
Bleeding at the access site.
Evaluated by clinical signs.
Measured: 24 hours after the procedure.
Neurological sequelae.
Evaluated by clinical signs.
Measured: 24 hours after the procedure.
Incidence of radial artery pseudoaneurysms.
Evaluated by clinical signs and ultrasound doppler.
Measured: 24 hours after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Feb 2022
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary InterventionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 482 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnoldo Enmanuel Loáisiga Sáenz, Instituto Nacional de Cardiologia Ignacio Chavez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966376
- Sponsor's protocol ID
- 21-1255
- Acronym
- HEMOSTAD-INC
- Status last verified
- Sep 2023
- First submitted
- 5 Apr 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Hemostatic Methods in Distal Radial Artery Approach for Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT05966376
- Acronym / sponsor ID
- HEMOSTAD-INC / 21-1255
- Conditions
- Coronary Intervention, Transradial Approach
- Keywords
- Distal Radial Artery Access, PreludeSYNC distal, Terumo Radial Band
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 482 participants (estimated)
- Lead sponsor
- Instituto Nacional de Cardiologia Ignacio ChavezUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 28 Jul 2023 (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.
Comparison of PreludeSYNC distal and Modified Terumo Radial Band in patients with distal radial approach.
Detailed description
INTRODUCTION AND BACKGROUND
Distal radial access at the level of the anatomical snuffbox and dorsal region of the hand has currently positioned itself as a viable and safe approach for procedures in interventional cardiology, whether diagnostic, simple, or complex angioplasties. We know that this approach method mainly reduces the occlusion rate of the proximal radial artery, among other advantages; however, we still do not have scientific evidence on the various hemostasis methods for this approach. Practice varies between centers and countries and hemostasis methods vary from an elastic compression bandage to the use of devices manufactured specifically for this approach such as the PreludeSYNC DISTAL or modification of devices manufactured for proximal radial hemostasis such as the TR band. In this clinical trial, we intend to analyze the efficacy and safety of two hemostasis methods in patients who require an interventional procedure (PredludeSYNC DISTAL vs modified TR band), to date, there is no clinical trial that compares these methods face to-face in relation to their efficacy and safety. Retrospective studies indicate that both methods are effective in reducing radial artery occlusion and are safe in reducing the bleeding/hematoma rate.
THE PURPOSE OF THE STUDY To compare the efficacy (distal radial artery occlusion) and safety (hematoma/bleeding) of two devices of distal radial hemostasis (PreludeSYNC distal and TR band) in patients undergoing percutaneous coronary intervention.
STUDY DESIGN Experimental, randomized, prospective, longitudinal, prolective, and comparative.
SUBJECTS OF STUDY Patients from the Ignacio Chávez National Institute of Cardiology who will undergo distal radial percutaneous coronary intervention/angiography.
METHODOLOGY After signing the informed consent, patients will be randomized by balanced block methods to: 1) Hemostasis using the PreludeSYNC distal device, or 2) Hemostasis using the Modified Radial Band device.
PRIMARY OUTCOME To compare the efficacy (distal radial artery occlusion) and safety (hematoma/bleeding) of PreludeSYNC distal versus Modified Terumo Radial Band in distal radial approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Terumo Radial Band | Experimental | Device: Hemostatic device for distal radial approach.A standard hemostatic device used for proximal radial approach. The hard plastic component is removed to achieve better attachment in the distal radial approach. * Clean and dry the puncture site. * The introducer is withdrawn 2 cm. * Place the device on the patient's hand depending on the approach side. * Terumo logo is positioned toward the little finger side. * The green mark is positioned 1 cm proximal to the puncture site. * The bands are adjusted and fixed around the wrist. * The Terumo syringe is filled with 15 ml of air. * The balloon of the device is slowly inflated through the valve while the introducer is slowly withdrawn simultaneously. * Once the introducer is completely withdrawn, the balloon continues to be inflated until the absence of bleeding is verified. * Once hemostasis is achieved, the patient must be able to move his fingers and wrist without bleeding. If bleeding is observed, the balloon is inflated to achieve adequate hemostasis. |
| PreludeSYNC distal | Active comparator | Device: Hemostatic device for distal radial approach.A specific hemostatic device, designed for distal radial approach. * Clean and dry the puncture site. * Selection and preparation of the PreludeSYNC distal device according to the approach side. * The introducer is withdrawn 2cm. * The hemostasis device is placed on the patient's hand. * Bands position: 1) little finger side; 2) thumb side; 3) between the thumb and the index finger. * The circular mark of the balloon is positioned 1cm proximal to the puncture site. * Bands are adjusted and fixed. * The syringe is filled with 10 ml of air. * The balloon of the device is slowly inflated while the introducer is slowly withdrawn simultaneously. * Once the introducer is completely withdrawn, the balloon continues to be inflated until the absence of bleeding is verified. * Once hemostasis is achieved, the patient must be able to move his fingers and wrist without bleeding. If bleeding is observed, the balloon should be inflated to achieve adequate hemostasis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Coronary artery disease including chronic coronary syndrome or acute coronary syndrome.
- Cardiovascular disease that requires coronary angiography in its approach.
Key exclusion criteria (11 listed)
- Cardiogenic shock.
- Lesions in venous or arterial hemoducts.
- Impossibility to provide informed consent.
- Chronic kidney disease on hemodialysis through arteriovenous fistula at the same site where the approach is planned.
- Severe chronic renal failure (GFR less than 30 ml/min/m2)
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 |
|---|---|---|
| Hemostatic device for distal radial approach.Also: PreludeSYNC distal, Terumo Radial BandHemostasis after distal radial approach is done with one of two devices, one of them is designed specifically for the distal radial approach; the other is not but a modified technique with the last one could be helpful. | Device | Modified Terumo Radial Band, PreludeSYNC distal |
Primary outcome
To compare the incidence of proximal radial artery occlusion assessed by ultrasound and the incidence of hematoma/bleeding assessed clinically by EASY scale of PreludeSYNC distal versus Modified Terumo Radial Band in distal radial approach.
Time frame: 24 hours after the procedure. Patients with radial occlusion at 24 hours will be follow at 30 days.
At 24 hours after the procedure, patients will be evaluated by interrogation, physical exam and ultrasonography. The absence of Doppler flow in the proximal radial artery at wrist level will define the occlusion of the radial artery. The EASY scale will be used to classify the severity of the hematoma in degrees from I to V according to the extension.
6 secondary outcomes
Incidence of distal and proximal radial artery occlusion at 24 hours after the procedure.
Time frame: 24 hours after the procedure.
Radial arterial patency at 30 days in patients with obstruction at 24 hours.
Time frame: 30 days after the procedure
Incidence of hematoma at the approach site.
Time frame: 24 hours after the procedure.
Bleeding at the access site.
Time frame: 24 hours after the procedure.
Neurological sequelae.
Time frame: 24 hours after the procedure.
Incidence of radial artery pseudoaneurysms.
Time frame: 24 hours after the procedure.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
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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 Hemostatic device for distal radial approach. in people with Coronary Intervention and Transradial Approach, run by Instituto Nacional de Cardiologia Ignacio Chavez at 1 site in Mexico.
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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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 Mexico. 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?
Results are not available in the source record.
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?
To compare the incidence of proximal radial artery occlusion assessed by ultrasound and the incidence of hematoma/bleeding assessed clinically by EASY scale of PreludeSYNC distal versus Modified Terumo Radial Band in distal radial approach. (time frame: 24 hours after the procedure. Patients with radial occlusion at 24 hours will be follow at 30 days.). 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 21 Sep 2023.