NCT05100940

Brief Summary

Coronary angiography and percutaneous coronary intervention (PCI) is often performed in patients with ischemic heart disease. The safety of PCI has improved with new devices and strategies, but complications still occur, especially during complex procedures. The objectives of this multi-center observational registry are to examine frequency of complications occuring during cardiac catheterization and PCI, examine procedural strategies utilized for complication management, and evaluate the clinical outcomes (both immediate and during follow-up.)

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Nov 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress54%
Nov 2020Dec 2030

Study Start

First participant enrolled

November 24, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 29, 2021

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

October 29, 2021

Status Verified

October 1, 2021

Enrollment Period

10.1 years

First QC Date

October 4, 2021

Last Update Submit

October 20, 2021

Conditions

Coronary Artery Disease

Keywords

complicationsPercutaneous Coronary intervention

Outcome Measures

Primary Outcomes (3)

  • in-hospital major cardiac adverse events (MACE)

    including any of the following adverse events prior to hospital discharge: death, stroke, myocardial infarction, recurrent angina requiring urgent repeat target vessel revascularization with PCI or coronary bypass surgery, and tamponade requiring pericardiocentesis or surgery.

    From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure

  • Technical Success of PCI

    Technical success of PCI will be defined as successful lesion recanalization by any method with achievement of \< 30% residual stenosis and TIMI 3 flow in both the main vessel and side branch. discharge: death, stroke, myocardial infarction, recurrent angina requiring urgent repeat target vessel revascularization with PCI or coronary bypass surgery, tamponade requiring pericardiocentesis or surgery); technical and procedural success; contrast volume, procedure time, fluoroscopy time, air kerma radiation dose.

    From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure

  • Procedural success of PCI

    Procedural success of PCI will be defined as achievement of technical success and with no in-hospital major adverse cardiac events (MACE).

    From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure

Interventions

Cardiac CatheterizationPROCEDURE

Cardiac Catheterization

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Over 18 years of age and undergoing coronary angiography or PCI and a complication occurred during or after the procedure at each of the participating centers.

* Over 18 years of age * undergoing coronary angiography or PCI * A complication occurred during or after the procedure

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

RECRUITING

Related Publications (1)

  • Mutlu D, Ser OS, Strepkos D, Carvalho PE, Alexandrou M, Kladou E, Mastrodemos O, Rangan BV, Sara JDS, Jalli S, Voudris K, Sandoval Y, Nicholas Burke M, Brilakis ES. Acute Kidney Injury Requiring Dialysis Following Percutaneous Coronary Intervention: Insights From the PROGRESS-COMPLICATIONS Registry. Catheter Cardiovasc Interv. 2025 Sep;106(3):1883-1891. doi: 10.1002/ccd.70012. Epub 2025 Jul 17.

    PMID: 40676818DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Cardiac Catheterization

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisCatheterizationTherapeuticsInvestigative Techniques

Central Study Contacts

Emmanouil Brilakis, MD, PhD

CONTACT

612-863-3852emmanouil.brilakis@allina.com

Bavana Rangan, BDS, MPH

CONTACT

612-863-3833bavana.rangan@allina.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2021

First Posted

October 29, 2021

Study Start

November 24, 2020

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

October 29, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)