Progress Complication

Recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT05100940
• Lead Sponsor: Minneapolis Heart Institute Foundation

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.)

Detailed 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.

Study Timeline

• Study Start: 2020-11-24
• Status Verified: 2021-10
• Study First Submitted: 2021-10-04
• Study First Submitted QC: 2021-10-20
• Last Update Submitted: 2021-10-20
• Study First Posted: 2021-10-29
• Last Update Posted: 2021-10-29
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical Success of PCI	From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure	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.
Procedural success of PCI	From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure	Procedural success of PCI will be defined as achievement of technical success and with no in-hospital major adverse cardiac events (MACE).
in-hospital major cardiac adverse events (MACE)	From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure	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.

Trial Locations

Locations (1)

Minneapolis Heart Institute Foundation; 🇺🇸 Minneapolis, Minnesota, United States