Progress Complication
ConditionCoronary Artery Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMinneapolis Heart Institute Foundation
About this trial
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.)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Over 18 years of age
undergoing coronary angiography or PCI
A complication occurred during or after the procedure
Disqualifiers
None
Trial 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.
Trial design
Design model
Case-only
Time perspective
Other
Treatments tested in this trial
Cardiac Catheterization
Procedure/SurgeryCardiac Catheterization
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure2
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.
Time frame
From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure3
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).
Time frame
From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedureSponsors and contacts
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Source ClinicalTrials.gov