Progress Complication

Coronary Artery Disease Clinical Trial

Official title:

Prospective Global Registry of Complications of Percutaneous Coronary Interventions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05100940
• Other study ID #: PROGRESS-COMPLICATION
• Status: Recruiting
• Start date: November 24, 2020
• Est. completion date: December 31, 2030

Study information

• Verified date: October 2021
• Source: Minneapolis Heart Institute Foundation
• Contact: Emmanouil Brilakis, MD, PhD
• Phone: 612-863-3852
• Email: emmanouil.brilakis[@]allina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.)

Description:

The safety of PCI has improved with new devices and strategies, but complications still occur, especially during complex procedures. Systematic study of cardiac procedure complications can improve procedural safety and optimize short and long-term patient outcomes. The objectives of this multi-center observational registry are to

1-Examine the frequency and types of complications occurring during cardiac catheterization and PCI among participating sites, 2-Examine the procedural strategies (techniques and devices) utilized for complication management, 3-Evaluate the clinical outcomes (both immediate and during follow-up) after each complication type.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4000
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2030
• Gender: All
• Age group: 18 Years and older

Eligibility

• Over 18 years of age

• undergoing coronary angiography or PCI

• A complication occurred during or after the procedure

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• Cardiac Catheterization
Cardiac Catheterization

Locations

Country	Name	City	State
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Heart Institute Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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