Clinical trial NCT04171570: DIStal Versus COnventional RADIAL Access for Coronary Angiography and Intervention
Official title: DISCO Radial Trial: DIStal Versus COnventional RADIAL Access for Coronary Angiography and Intervention: a Randomized Multicenter Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Disease
Keywords: Distal Transradial Access
Randomized Multicenter Trial
Radial Access
Lead sponsor: Terumo Europe N.V.
Sponsor class: INDUSTRY
Collaborators: name: Cromsource
First posted: 2019-11-21
Enrollment: 1309
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization to distal transradial access or conventional transradial access. Both techniques are standard of care.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study is to demonstrate the superiority of Distal Radial Access (DTRA) to Conventional Transradial Access (CTRA) regarding forearm radial artery occlusion (RAO).

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).

Detailed description: DISCO RADIAL is a prospective, global, open label, multi-centre randomized controlled trial with plan to include approximately 1300 patients on who transradial coronary angiography and/or intervention is performed. The patients will be randomized in 1:1 ratio to either Distal Transradial Artery Access (DTRA) or Conventional Transradial Access (CTRA) arm. In both arms 6Fr Glidesheath Slender (GSS) will be used as access sheath.

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.

Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years of age.
* 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:

* Patient has a medical condition that may cause non-compliance with the protocol and/or confound the data interpretation.
* Patients on chronic hemodialysis.
* Patients presenting with ST-elevated myocardial infarction (STEMI).
* Patients have chronic total occlusion (CTO) lesions in coronary artery.

Primary outcomes:
measure: Forearm radial artery occlusion (RAO) rate before discharge
timeFrame: up to 5 days
Secondary outcomes:
measure: Rate of successful sheath insertion
timeFrame: up to 2 days
measure: Rate of access site crossover
timeFrame: up to 2 days
measure: Total procedural time
timeFrame: up to 2 days
measure: Sheath insertion time
timeFrame: up to 2 days
measure: Puncture site bleeding according to EASY criteria
timeFrame: up to 5 days
measure: Overall bleeding according to BARC criteria
timeFrame: up to 5 days
measure: Vascular access-site complication
timeFrame: up to 5 days
measure: Rate of radial artery spasm
timeFrame: up to 2 days
measure: Rate of distal radial artery occlusion (dRAO)
timeFrame: up to 5 days
measure: Patent hemostasis was achieved or not (CTRA) by reverse barbeau test
timeFrame: up to 5 days
measure: Time required to reach hemostasis
timeFrame: up to 5 days
measure: Pain associated with the procedure: Visual Assessment Scale (VAS)
timeFrame: up to 5 days
Other outcomes:
Locations:
city: Woluwe-Saint-Lambert
country: Belgium
facility: Cliniques Universitaires Saint-Luc
state: Bruxelles
city: Charleroi
country: Belgium
facility: Hôpital Civil Marie Curie
state: Hainaut
city: Haine-Saint-Paul
country: Belgium
facility: CHU Jolimont
state: Hainaut
city: Brussel
country: Belgium
facility: UZ Brussel
city: Plzen
country: Czechia
facility: Plzen Medical University
city: Minden
country: Germany
facility: University Hospital Johannes Wesling Klinikum Minden
city: Kecskemet
country: Hungary
facility: Bács-Kiskun Megyei Kórház
city: Roma
country: Italy
facility: Sant'Eugenio Hospital
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Kanagawa
country: Japan
facility: Shonan Kamakura General Hospital
city: Zwolle
country: Netherlands
facility: Isala Hospital
city: Skopje
country: North Macedonia
facility: University Clinic of Cardiology, Skopje
city: Geneva
country: Switzerland
facility: HUG Geneva
city: Liestal
country: Switzerland
facility: Kantonsspital Baselland Liestal
city: Stoke-on-Trent
country: United Kingdom
facility: Royal Stoke University Hospital
city: Sunderland
country: United Kingdom
facility: Sunderland Royal Hospital
Study officials:
affiliation: Hôpital Civil Marie Curie
name: Adel Aminian, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.