EXTended pRotective Curtain Under Table to Reduce Operator RAdiation Dose in Percutaneous Coronary Procedures

NCT03259126 | Completed

• 1 other identifier: Pertini05
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

Radiation dose to interventional cardiologists performing transradial percutaneous coronary procedures is higher compared to those performing transfemoral exams. The radiation dose seems particularly high at pelvic level. We prepared an home-made protective extension of the leaded curtain under table that should reduce the operator exposure during interventional coronary procedures. The aim of the study is to evaluate the procedural efficacy of the protective extension on the operator radiation dose at pelvic level

Conditions

Radiation; X-rays; Effects; Coronary Disease

Keywords

Transradial; Coronary; X-ray; Radiation; Curtain

Outcome Measures

Primary Outcomes (1)

• Operator pelvic dose

  Operator radiation dose at pelvic level

  24 hours

Secondary Outcomes (3)

• Operator thorax dose

  24 hours

• Operator head dose

  24 hours

• Operator pelvic dose and experimental curtain utilized

  24 hours

Study Arms (2)

SCUT

EXPERIMENTAL

Use of a "Small Curtain under table" (SCUT) placed under the cranial part of the angiographic table

Device: SCUT

Control

NO INTERVENTION

Control Group without the SCUT

Interventions

SCUT DEVICE

Two different home made curtains were attached to the angiographic table

SCUT

Eligibility Criteria

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

You may qualify if:

• all patient undergoing percutaneous coronary procedures through transradial access

You may not qualify if:

• Interventions performed through a different vascular access
• Procedures performed in patients with ST elevation acute myocardial infarction
• Haemodynamic instability
• Lack of written informed consent
• Age \< 18 years old
• Previous coronary artery by-pass

Sponsors & Collaborators

• Ospedale Sandro Pertini, Roma: lead

Study Sites (1)

Ospedale Sandro Pertini

Rome, Lazio, 00168, Italy

Location

Related Publications (1)

• Sciahbasi A, Sarandrea A, Rigattieri S, Patrizi R, Cera M, Di Russo C, Zezza L, Fedele S, Ferraiuolo G. Extended Protective Shield Under Table to Reduce Operator Radiation Dose in Percutaneous Coronary Procedures. Circ Cardiovasc Interv. 2019 Feb;12(2):e007586. doi: 10.1161/CIRCINTERVENTIONS.118.007586.

  PMID: 30732471 DERIVED

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Alessandro Sciahbasi, MD, PhD

  Ospeadale Sandro Pertini ASL RM2

  PRINCIPAL INVESTIGATOR

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: MD, PhD

Model Details: Comparison of operator radiation dose at pelvic level during percutaneous coronary procedures through transradial access with or without an extension of the leaded curtain under table

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 23, 2017
• Study Start: August 7, 2017
• Primary Completion: August 13, 2018
• Study Completion: August 13, 2018
• Last Updated: August 20, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)