DIStal Versus COnventional RADIAL Access for Coronary Angiography and Intervention
NCT ID: NCT04171570
Last Updated: 2022-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1309 participants
INTERVENTIONAL
2019-12-10
2021-12-28
Brief Summary
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This trial plans to include 1300 patients in around 12 locations around the world (11 participating sites in Europe and 1 participating site in Japan).
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Detailed Description
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The sponsor will work in accordance with standard operating procedures (SOP) and the Monitoring Plan in order to ensure adherence to the CIP and applicable regulations at the investigational sites.
The Monitoring Plan is built according to a risk-based monitoring approach and describes the level of source data verification to be performed by the monitors.
Risk-based monitoring approach uses all available means to supervise the trial (central monitoring, remote monitoring and on-site monitoring), focusing in critical data points and issues ensuring that adequate monitoring (central, remote and on-site) at each site is completed to ensure protection of the rights and safety of the subjects and the quality and integrity of the data collected and submitted.
The sponsor shall provide training and the necessary guidelines to assist each investigational site on the data collection in the eCRF. Each site is responsible to report the available data requested by the CIP. In order to ensure data quality and avoid missing information in the eCRF, edit checks are designed during database development. In addition, Sponsor's CRA and Data Management team will be responsible to review the data and raise queries accordingly into the eCRF. An audit trail logging all data entered and edited is available within the EDC system. All source documents are maintained in the hospital files ready for inspection by the Sponsor and regulatory authorities upon request. The Sponsor will inform the investigator of the time period for retaining these records as per applicable regulatory requirements.
The following analysis sets will be considered for the statistical analysis :
As Treated Population This population includes all patients who were treated and undergo the studied procedure. Patients will be assigned to the study treatement groups according to the actual received treatement.
Intention-To-Treat Population This population includes all patients who have been randomized to a treatement. Patients will be assigned to the study treatement groups according to the treatement to which they have been randomized.
Per-Protocol Population This population includes all patients who were treated and undergo the studied procedure, excluding all patients with major violations to the protocol (e.g. wrong inclusion, missing data, mis-randomization, crossover, drop off before discharge). Patients will be assigned to the study treatement groups according to the treatement to which they have been randomized. All the protocol deviations will be reported in statistical report.
Assuming a rate of forearm RAO of 1% in DTRA and 3.5% in CTRA based on on two-sided alpha = 0.050 and power = 80%, 1:1 randomization needs 551 patients for each group to detect statistically significant differences in forearm RAO proportions. Then, given the crossover rate of 10% and the drop out rate of 5% for both group, at least 648 patients needs for each group to maintain proper statistical power. In total 1300 subjects will be randomized.
The primary endpoint analysis will be performed on ITT (Intention-To-Treat) population, by using two-sided superiority test with alpha = 0.05. Due to the short observation period (3 days ±2), a low number of missing data is expected. However, in case it exceeds 15-20%, missing, unused or spurious data will be considered using a tipping point analysis for each population. The comparaison in RAO rates between treatment groups will be tested by Chi-squared tests or Fisher's exact test, as appropriate. Odd-Ratio with IC95% will be calculated. Logistic regression analyses will be used to test the tendency.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Distal Transradial Access
Distal Transradial Access
Coronary angiography and or Percutaneous coronary Intervention
Radial access punture site
Conventional Transradial Access
Conventional Transradial Access
Coronary angiography and or Percutaneous coronary Intervention
Radial access punture site
Interventions
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Coronary angiography and or Percutaneous coronary Intervention
Radial access punture site
Eligibility Criteria
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Inclusion Criteria
* Patient has provided written informed consent.
* Patient is undergoing diagnostic coronary angiography and/or PCI.
* Patient is willing to comply with all protocol-required evaluations during the hospitalization.
* Patient is suitable for both DTRA and CTRA using 6Fr GSS.
Exclusion Criteria
* Patients on chronic hemodialysis.
* Patients presenting with ST-elevated myocardial infarction (STEMI).
* Patients have chronic total occlusion (CTO) lesions in coronary artery.
18 Years
ALL
No
Sponsors
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Cromsource
INDUSTRY
Terumo Europe N.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Adel Aminian, Dr.
Role: PRINCIPAL_INVESTIGATOR
Hôpital Civil Marie Curie
Locations
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Cliniques Universitaires Saint-Luc
Woluwe-Saint-Lambert, Brussels Capital, Belgium
Hôpital Civil Marie Curie
Charleroi, Hainaut, Belgium
CHU Jolimont
Haine-Saint-Paul, Hainaut, Belgium
UZ Brussel
Brussels, , Belgium
Plzen Medical University
Pilsen, , Czechia
University Hospital Johannes Wesling Klinikum Minden
Minden, , Germany
Bács-Kiskun Megyei Kórház
Kecskemét, , Hungary
Sant'Eugenio Hospital
Roma, , Italy
Istituto Clinico Humanitas
Rozzano, , Italy
Shonan Kamakura General Hospital
Kanagawa, , Japan
Isala Hospital
Zwolle, , Netherlands
University Clinic of Cardiology, Skopje
Skopje, , North Macedonia
HUG Geneva
Geneva, , Switzerland
Kantonsspital Baselland Liestal
Liestal, , Switzerland
Royal Stoke University Hospital
Stoke-on-Trent, , United Kingdom
Sunderland Royal Hospital
Sunderland, , United Kingdom
Countries
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References
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Kiemeneij F. Left distal transradial access in the anatomical snuffbox for coronary angiography (ldTRA) and interventions (ldTRI). EuroIntervention. 2017 Sep 20;13(7):851-857. doi: 10.4244/EIJ-D-17-00079.
Corcos T. Distal radial access for coronary angiography and percutaneous coronary intervention: A state-of-the-art review. Catheter Cardiovasc Interv. 2019 Mar 1;93(4):639-644. doi: 10.1002/ccd.28016. Epub 2018 Dec 11.
Sgueglia GA, Di Giorgio A, Gaspardone A, Babunashvili A. Anatomic Basis and Physiological Rationale of Distal Radial Artery Access for Percutaneous Coronary and Endovascular Procedures. JACC Cardiovasc Interv. 2018 Oct 22;11(20):2113-2119. doi: 10.1016/j.jcin.2018.04.045.
Aminian A, Saito S, Takahashi A, Bernat I, Jobe RL, Kajiya T, Gilchrist IC, Louvard Y, Kiemeneij F, Van Royen N, Yamazaki S, Matsukage T, Rao SV. Comparison of a new slender 6 Fr sheath with a standard 5 Fr sheath for transradial coronary angiography and intervention: RAP and BEAT (Radial Artery Patency and Bleeding, Efficacy, Adverse evenT), a randomised multicentre trial. EuroIntervention. 2017 Aug 4;13(5):e549-e556. doi: 10.4244/EIJ-D-16-00816.
Other Identifiers
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T133E3
Identifier Type: -
Identifier Source: org_study_id
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