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Anatomical sNuffbox for Coronary anGiography and IntervEntions (ANGIE)

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ClinicalTrials.gov Identifier: NCT03986151
Recruitment Status : Recruiting
First Posted : June 14, 2019
Last Update Posted : June 18, 2019
Sponsor:
Information provided by (Responsible Party):
Tsigkas Grigorios, University Hospital of Patras

Brief Summary:
This randomized, single-center, prospective study seeks to compare the conventional radial approach with the recently described distal radial approach (anatomical snuffbox) concerning the patency of the radial artery in patients subjected to coronary angiography or percutaneous coronary intervention.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Vascular Access Complication Procedure: Coronary angiography +/- percutaneous coronary intervention Not Applicable

Detailed Description:
Transradial approach has become the standard approach for coronary angiography (CAG) and percutaneous coronary intervention (PCI). The current ESC/EACTS guidelines of myocardial revascularization support using radial approach (RA) rather than femoral approach (FA) if the operators are experts for RA. Recently, an alternative transradial access has been suggested at the anatomical snuffbox, with potential additional benefits including a reduction in radial artery occlusion rate (which allows reintervention through the same access site and potential use as a graft), a decrease in other local vascular complications, shorter hemostasis duration, patients' intra and post procedural comfort and shorter recovery time. However, the feasibility of PCI via snuffbox approach is still concerned due to the lack of data. Therefore, the aim of the study is to compare the two approaches concerning the patency of the radial artery 30 (+/-10) days after the intervention with Doppler in a randomized way. Due to the anastomosis of the distal radial artery with the superficial palmar arch, even in case of total radial artery occlusion within the anatomical snuffbox, the antegrade blood flow may be preserved and, therefore, decreased incidents of radial artery occlusion are expected in the right distal radial artery approach group. The mean diameter of radial artery at the anatomical snuffbox is 2.4 mm, whereas the mean diameter of the radial artery at the forearm is 2.7 mm, and this could potentially contribute to shorter hemostasis duration.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 774 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Anatomical sNuffbox for Coronary anGiography and IntervEntions
Actual Study Start Date : June 11, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : February 10, 2021

Arm Intervention/treatment
Active Comparator: Conventional radial access Procedure: Coronary angiography +/- percutaneous coronary intervention
Comparison of the conventional radial approach with the distal radial approach (anatomical snuffbox)

Experimental: Distal radial access Procedure: Coronary angiography +/- percutaneous coronary intervention
Comparison of the conventional radial approach with the distal radial approach (anatomical snuffbox)




Primary Outcome Measures :
  1. Rate of right radial artery occlusion [ Time Frame: 30 (+/-10) days after CAG or PCI ]

Secondary Outcome Measures :
  1. Rate of successful insertion of the sheath [ Time Frame: Immediately post-procedurally ]
  2. Duration of sheath insertion procedure [ Time Frame: Immediately post-procedurally ]
  3. Rate of successful completion of coronary angiography [ Time Frame: Immediately post-procedurally ]
  4. Rate of successful completion of percutaneous coronary intervention [ Time Frame: Immediately post-procedurally ]
  5. Total Contrast volume [ Time Frame: Immediately post-procedurally ]
  6. Total Fluoroscopy time [ Time Frame: Immediately post-procedurally ]
  7. Total Radiation Dose [ Time Frame: Immediately post-procedurally ]
  8. Total Procedure Time [ Time Frame: Immediately post-procedurally ]
  9. Time required for hemostasis [ Time Frame: 1-6 hours ]
  10. Postprocedural Hematoma (modified EASY class) [ Time Frame: 3 hours ]
  11. Rate of distal radial artery occlusion [ Time Frame: 30 (+/-10) days after CAG or PCI ]
  12. Pain associated with the procedure: Pain scale 0-10 [ Time Frame: 1 hour ]
    Pain scale 0-10. A visual anlog pain scale 0-10 will be shown to the patient post-precedurally. 0=no pain, 10=worst pain. Patient will be asked to report the severity of the pain associated with the procedure.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Indication for coronary angiography
  • Informed consent

Exclusion Criteria:

  • Non palpable right radial artery
  • Prior complicated right transradial intervention (radial artery dissection, perforation, occlusion)
  • Prior CABG
  • STEMI
  • Hemodynamic instability
  • Anatomical restrictions (fistula, etc)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03986151


Contacts
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Contact: Grigorios Tsigkas, MD, PhD +306974466662 gregtsig@hotmail.com

Locations
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Greece
University Hospital of Patras Recruiting
Patras, Achaia, Greece, 26504
Contact: Grigorios Tsigkas    00306974466662    gregtsig@hotmail.com   
Contact: Aggeliki Papageorgiou    +306934475309    aggelikip.1502@gmail.com   
Principal Investigator: Grigorios Tsigkas, MD, PhD         
Principal Investigator: Periklis Davlouros, MD, PhD         
Principal Investigator: Georgios Hahalis, MD, PhD         
Sponsors and Collaborators
University Hospital of Patras
Investigators
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Principal Investigator: Grigorios Tsigkas, MD, Phd University Hospital of Patras

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Responsible Party: Tsigkas Grigorios, Cardiology consultant, University Hospital of Patras
ClinicalTrials.gov Identifier: NCT03986151     History of Changes
Other Study ID Numbers: 11994/6-5-2019
First Posted: June 14, 2019    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tsigkas Grigorios, University Hospital of Patras:
coronary angiography
radial access
distal radial access
anatomical snuffbox
radial artery occlusion

Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases