Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI

NCT06013813 | Unknown DMC

• 1 other identifier: 23-1367
• Study Type: interventional
• Target: 2,922
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to compare conventional radial access versus distal radial access in patients with STEMI undergoing PCI. The main question it aims to answer is:

• Mayor adverse cardiac events (MACE) at 30 days in STEMI patients treated by PCI are not inferior when comparing the distal radial approach versus the conventional radial approach ? Participants will:
• sign the informed consent to enroll in the clinical trial.
• will agree to be treated by PCI
• will be randomized 1:1 to perform PCI by conventional radial or distal radial approach. If there is a comparison group: Researchers will compare conventional radial access vs distal radial access to see if the distal approach is not inferior compared to the conventional radial access in order to offer less or equal MACE and a similar rate of a successful procedure.

Conditions

STEMI - ST Elevation Myocardial Infarction; Myocardial Infarction; Acute Coronary Syndrome

Keywords

STEMI; distal radial access; conventional radial access; MACE

Outcome Measures

Primary Outcomes (1)

• Composite of adverse events of all-cause mortality, myocardial infarction, cerebral vascular event, BARC 3-5 (Bleeding Academic Research Consortium), myocardial infarction and cerebrovascular event, bleeding measure will be with BARC classification.

  At 24 hours and 30 days after the procedure, patients will be evaluated by radial doppler ultrasonography, lab test, and interrogation of clinical adverse events during hospital stay or 30 days after PCI.

  24 hours and 30 days after PCI.

Secondary Outcomes (5)

• Incidence of myocardial infarction after the procedure

  24 hours to 30 days after PCI

• Incidence of cerebral vascular event (hemorrhagic or ischemic stroke) after the procedure

  24 hours to 30 days after PCI.

• Urgent TVR (Revascularization of the treated vessel)

  If the patient requires repeat catheterisation for myocardial infarction within the first 30 days after PCI.

• Definite stent thrombosis

  If the patient requires repeat catheterisation for myocardial infarction within the first 30 days after PCI.

• Bleeding assessed by BARC 3-5 to 30 days of evolution in patients with STEMI who received interventional treatment via RD access versus RC access.

  24 hours to 30 days after PCI.

Study Arms (2)

Distal radial approach

EXPERIMENTAL

* Clean and dry the puncture site. * Simple lidocaine 2% is infiltrated. * The artery is punctured in the radial distal zone, and a 6 Fr hydrophilic radial introducer is placed with the Seldinger technique. * Verapamil 2.5 mg and Heparin 5000 IU are administered. * PCI is performed. * Finally, the introducer is withdrawn with the patent hemostasis technique, and a radial compression device is placed (prelude mostly or terumo).

Procedure: Radial Artery approach on percutaneous coronary intervention (PCI)

Conventional radial approach (proximal radial approach).

ACTIVE COMPARATOR

* Clean and dry the puncture site. * Simple lidocaine 2% is infiltrated. * The artery is punctured in the radial proximal zone, and a 6 Fr hydrophilic radial introducer is placed with the Seldinger technique. * Verapamil 2.5 mg and Heparin 5000 IU are administered. * PCI is performed. * Finally, the introducer is withdrawn with the patent hemostasis technique, and a radial compression device is placed (terumo).

Procedure: Radial Artery approach on percutaneous coronary intervention (PCI)

Interventions

Radial Artery approach on percutaneous coronary intervention (PCI) PROCEDURE

* Randomized patients with a right patent radial artery. * The outcomes of the distal radial approach will be compared with those of the conventional radial approach. * Technique and devices (introducer and compression devices) are the same in both approaches.

Conventional radial approach (proximal radial approach).; Distal radial approach

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• STEMI patients underwent PCI.
• Patent radial access (distal and conventional)
• Patients who agree to participate in the study and sign the informed consent form.

You may not qualify if:

• Cardiogenic shock.
• Previous coronary artery bypass grafting (CABG).
• Absence of palpable radial pulse.
• Arteriovenous fistula for hemodialysis.
• Previous radial artery occlusion.

Sponsors & Collaborators

• Instituto Nacional de Cardiologia Ignacio Chavez: lead

Study Sites (1)

Instituto Nacional de Cardiología Ignacio Chávez

Mexico City, Mexico

RECRUITING

Related Publications (14)

• Mason PJ, Shah B, Tamis-Holland JE, Bittl JA, Cohen MG, Safirstein J, Drachman DE, Valle JA, Rhodes D, Gilchrist IC; American Heart Association Interventional Cardiovascular Care Committee of the Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Peripheral Vascular Disease; and Council on Genomic and Precision Medicine. An Update on Radial Artery Access and Best Practices for Transradial Coronary Angiography and Intervention in Acute Coronary Syndrome: A Scientific Statement From the American Heart Association. Circ Cardiovasc Interv. 2018 Sep;11(9):e000035. doi: 10.1161/HCV.0000000000000035.

  PMID: 30354598 BACKGROUND

• Mamas MA, Anderson SG, Carr M, Ratib K, Buchan I, Sirker A, Fraser DG, Hildick-Smith D, de Belder M, Ludman PF, Nolan J; British Cardiovascular Intervention Society; National Institute for Cardiovascular Outcomes Research. Baseline bleeding risk and arterial access site practice in relation to procedural outcomes after percutaneous coronary intervention. J Am Coll Cardiol. 2014 Oct 14;64(15):1554-64. doi: 10.1016/j.jacc.2014.05.075.

  PMID: 25301457 BACKGROUND

• Ferrante G, Rao SV, Juni P, Da Costa BR, Reimers B, Condorelli G, Anzuini A, Jolly SS, Bertrand OF, Krucoff MW, Windecker S, Valgimigli M. Radial Versus Femoral Access for Coronary Interventions Across the Entire Spectrum of Patients With Coronary Artery Disease: A Meta-Analysis of Randomized Trials. JACC Cardiovasc Interv. 2016 Jul 25;9(14):1419-34. doi: 10.1016/j.jcin.2016.04.014. Epub 2016 Jun 29.

  PMID: 27372195 BACKGROUND

• Valgimigli M, Gagnor A, Calabro P, Frigoli E, Leonardi S, Zaro T, Rubartelli P, Briguori C, Ando G, Repetto A, Limbruno U, Cortese B, Sganzerla P, Lupi A, Galli M, Colangelo S, Ierna S, Ausiello A, Presbitero P, Sardella G, Varbella F, Esposito G, Santarelli A, Tresoldi S, Nazzaro M, Zingarelli A, de Cesare N, Rigattieri S, Tosi P, Palmieri C, Brugaletta S, Rao SV, Heg D, Rothenbuhler M, Vranckx P, Juni P; MATRIX Investigators. Radial versus femoral access in patients with acute coronary syndromes undergoing invasive management: a randomised multicentre trial. Lancet. 2015 Jun 20;385(9986):2465-76. doi: 10.1016/S0140-6736(15)60292-6. Epub 2015 Mar 16.

  PMID: 25791214 BACKGROUND

• Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.

  PMID: 21670242 BACKGROUND

• Jolly SS, Yusuf S, Cairns J, Niemela K, Xavier D, Widimsky P, Budaj A, Niemela M, Valentin V, Lewis BS, Avezum A, Steg PG, Rao SV, Gao P, Afzal R, Joyner CD, Chrolavicius S, Mehta SR; RIVAL trial group. Radial versus femoral access for coronary angiography and intervention in patients with acute coronary syndromes (RIVAL): a randomised, parallel group, multicentre trial. Lancet. 2011 Apr 23;377(9775):1409-20. doi: 10.1016/S0140-6736(11)60404-2. Epub 2011 Apr 4.

  PMID: 21470671 BACKGROUND

• Mehta SR, Jolly SS, Cairns J, Niemela K, Rao SV, Cheema AN, Steg PG, Cantor WJ, Dzavik V, Budaj A, Rokoss M, Valentin V, Gao P, Yusuf S; RIVAL Investigators. Effects of radial versus femoral artery access in patients with acute coronary syndromes with or without ST-segment elevation. J Am Coll Cardiol. 2012 Dec 18;60(24):2490-9. doi: 10.1016/j.jacc.2012.07.050. Epub 2012 Oct 24.

  PMID: 23103036 BACKGROUND

• Ferrante G, Condello F, Rao SV, Maurina M, Jolly S, Stefanini GG, Reimers B, Condorelli G, Lefevre T, Pancholy SB, Bertrand O, Valgimigli M. Distal vs Conventional Radial Access for Coronary Angiography and/or Intervention: A Meta-Analysis of Randomized Trials. JACC Cardiovasc Interv. 2022 Nov 28;15(22):2297-2311. doi: 10.1016/j.jcin.2022.09.006.

  PMID: 36423974 BACKGROUND

• Eid-Lidt G, Rivera Rodriguez A, Jimenez Castellanos J, Farjat Pasos JI, Estrada Lopez KE, Gaspar J. Distal Radial Artery Approach to Prevent Radial Artery Occlusion Trial. JACC Cardiovasc Interv. 2021 Feb 22;14(4):378-385. doi: 10.1016/j.jcin.2020.10.013.

  PMID: 33602433 BACKGROUND

• Bernat I, Aminian A, Pancholy S, Mamas M, Gaudino M, Nolan J, Gilchrist IC, Saito S, Hahalis GN, Ziakas A, Louvard Y, Montalescot G, Sgueglia GA, van Leeuwen MAH, Babunashvili AM, Valgimigli M, Rao SV, Bertrand OF; RAO International Group. Best Practices for the Prevention of Radial Artery Occlusion After Transradial Diagnostic Angiography and Intervention: An International Consensus Paper. JACC Cardiovasc Interv. 2019 Nov 25;12(22):2235-2246. doi: 10.1016/j.jcin.2019.07.043.

  PMID: 31753298 BACKGROUND

• Eid-Lidt G, Reyes-Carrera J, Farjat-Pasos JI, Saenz AL, Bravo CA, Rangel SN, Salido DZ, Vega Servin NS, Soto-Lopez ME, Gaspar J. Prevention of Radial Artery Occlusion of 3 Hemostatic Methods in Transradial Intervention for Coronary Angiography. JACC Cardiovasc Interv. 2022 May 23;15(10):1022-1029. doi: 10.1016/j.jcin.2022.03.011.

  PMID: 35589232 BACKGROUND

• Aminian A, Sgueglia GA, Wiemer M, Kefer J, Gasparini GL, Ruzsa Z, van Leeuwen MAH, Ungureanu C, Leibundgut G, Vandeloo B, Kedev S, Bernat I, Ratib K, Iglesias JF, Al Hage E, Posteraro GA, Pascut D, Maes F, Regazzoli D, Kakonyi K, Meijers TA, Colletti G, Krivoshei L, Lochy S, Zafirovska B, Horak D, Nolan J, Degrauwe S, Tobita K, Saito S. Distal Versus Conventional Radial Access for Coronary Angiography and Intervention: The DISCO RADIAL Trial. JACC Cardiovasc Interv. 2022 Jun 27;15(12):1191-1201. doi: 10.1016/j.jcin.2022.04.032. Epub 2022 May 17.

  PMID: 35595673 BACKGROUND

• Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.

  PMID: 30165437 RESULT

• Writing Committee Members; Lawton JS, Tamis-Holland JE, Bangalore S, Bates ER, Beckie TM, Bischoff JM, Bittl JA, Cohen MG, DiMaio JM, Don CW, Fremes SE, Gaudino MF, Goldberger ZD, Grant MC, Jaswal JB, Kurlansky PA, Mehran R, Metkus TS Jr, Nnacheta LC, Rao SV, Sellke FW, Sharma G, Yong CM, Zwischenberger BA. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 Jan 18;79(2):e21-e129. doi: 10.1016/j.jacc.2021.09.006. Epub 2021 Dec 9.

  PMID: 34895950 RESULT

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Myocardial Infarction; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Guering Eid Lidt, PhD

  Guering Eid-Lidt

  STUDY CHAIR

Central Study Contacts

Juan Carlos Plata Corona, PhD

CONTACT

+522212187940; juancarlosplatacorona3@gmail.com

Guering Eid Lidt, PhD

CONTACT

+525585803787; gueringeid@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiac Catheterization Lab

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 28, 2023
• Study Start: September 7, 2023
• Primary Completion: December 1, 2024
• Study Completion: February 1, 2025
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: january 2025 to january 2026
• Access Criteria: IPD will be shared for related studies, without distinctions in the nature of each study, information may be freely requested directly by e-mail and each request will be evaluated by the principal investigator of the study.

Locations

ME (1)