Contrast Volume Reduction During PCI With the Use of a New Assisting Software Package

NCT02927990 | Terminated Results

• 1 other identifier: XCY607-130198
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The new software package is intended to assist the physician in imaging the coronaries during percutaneous coronary interventions. This study investigates the amount of contrast used during percutaneous coronary interventions with the aid of the new software package. The results of the study will be compared with control group data (before the new software package was installed or after it was removed) to define a possible contrast reduction.

Conditions

Coronary Stenosis; Coronary Occlusion

Outcome Measures

Primary Outcomes (1)

• Amount [mL] of Contrast Used for Completion of the Coronary Intervention

  Phase 2 not initiated Only phase 1 data was collected

  Amount of contrast [mL] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.

Secondary Outcomes (4)

• Cumulative Dose Area Product (DAP) of Percutaneous Coronary Intervention

  DAP [mGycm^2] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.

• Cumulative Air-Kerma (AK) of Percutaneous Coronary Intervention

  AK [mGy] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.

• Total Fluoroscopy Time of Percutaneous Coronary Intervention

  Fluoroscopy time [minutes] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.

• Procedure Efficiency

  Patients will be followed from start of interventional procedure (vascular access obtained) until end of the procedure (vascular closure), ranging between 30 minutes and a few hours.

Other Outcomes (2)

• Amount of Vessels Treated During Percutaneous Coronary Intervention

  Amount [number] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.

• Quality of Roadmap Images

  Quality [score] will be determined once, at the end of the Percutaneous Coronary Intervention. There is no patient follow-up.

Study Arms (2)

Study group

Percutaneous coronary interventions with additional imaging provided by the new software package

Other: Percutaneous Coronary Intervention

Control group

Percutaneous coronary interventions without the new software package

Other: Percutaneous Coronary Intervention

Interventions

Percutaneous Coronary Intervention OTHER

Percutaneous Coronary Intervention according to standard of care

Control group; Study group

Eligibility Criteria

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

Study Population

Patients with age 18 or older, of both genders and all races. Patients undergoing a percutaneous coronary intervention. Patients are considered to be enrolled in the study after they have signed the informed consent form.

You may qualify if:

• Subject undergoing a percutaneous coronary intervention.
• Subject 18 years of age or older, or of legal age to give informed consent per state or national law.

You may not qualify if:

• Subject undergoing an emergency treatment
• Primary angioplasty for acute ST segment elevation myocardial infarction.
• Subject with contrast allergies
• Subject with severe kidney disease (e-GFR \< 40 by Modification of Diet in Renal Disease (MDRD)/Cockcroft Gault clearance formula and/or upon decision by investigator)
• Subject participates in a potentially confounding drug or device trial during the course of the study.
• Prisoners, people who cannot legally give consent, pregnant women and breastfeeding women.

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (1)

Columbia University Medical Center/NYPH

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Coronary Stenosis; Coronary Occlusion

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Results Point of Contact

• Title: Pim van Lochem
• Organization: Philips Medical Systems B.V.

pim.vanlochem@philips.com

+31 (0)634322891

Study Officials

• Manish Parikh, MD

  Columbia University Medical Center/NYPH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: October 7, 2016
• Study Start: December 15, 2017
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: December 6, 2024
• Results First Posted: December 6, 2024

Record last verified: 2024-12

Locations

US (1)