In-hospital and Long-term Outcomes for Percutaneous Chronic Total Coronary Occlusion Revascularization in a High-volume, Multi-operator Program (Perspective)
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|ClinicalTrials.gov Identifier: NCT01946724|
Recruitment Status : Completed
First Posted : September 20, 2013
Last Update Posted : May 4, 2018
|Condition or disease|
|Ischemic Heart Disease|
The purpose of this study is to study whether percutaneous chronic total occlusion (CTO) revascularization, by the use of Percutaneous Coronary Intervention (PCI), stenting, guidewire, and catheter, improves a patient's quality of life and their left ventricular function, reduces angina severity, and improves long-term survival. The study will consist of the two following groups:
Retrospective patients This group will consist of consecutive patients that have already undergone CTO PCI by the PHI CTO team.
- The patients will be contacted by telephone for informed consent and will be asked how they are feeling and if they have seen any doctors for their heart conditions. The patient will also be asked if they are taking antiplatelet medicines as prescribed, and if there have been any changes in on their medicines.
- If more than 12 months have passed since the procedure, the patients will be queried regarding medical history
- If the patient cannot be contacted, then analysis of data will be limited to de-identified data collected from the chart, procedure angiogram, and the procedure report.
Prospective patients This group will consist of patients in which the CTO procedure will be performed by the PHI CTO team.
- A clinical assessment will be performed before the stent procedure
- A blood sample will be taken for routine blood chemistry and hematology
- Medications will be prescribed to prevent blood clots
- Follow-up will occur 6 and 12 months post-procedure
|Study Type :||Observational|
|Actual Enrollment :||500 participants|
|Official Title:||A Single Center, Observational Study to Evaluate Procedural, In-hospital and Long-term Outcomes for Percutaneous Chronic Total Coronary Occlusion Revascularization in a High-volume, Multi-operator Program|
|Actual Study Start Date :||August 2013|
|Actual Primary Completion Date :||May 24, 2017|
|Actual Study Completion Date :||May 24, 2017|
- CTO procedural success [ Time Frame: 1 year ]CTO procedural success as defined by an achievement of a final residual angiographic stenosis < 50% within the treated segment with >=TIMI 2 antegrade flow.
- Major Adverse Cardiac Events (MACE) [ Time Frame: Prior to Index Hospitalization Discharge (< 1 year from procedure) ]The occurrence of major adverse cardiac events (MACE): death, myocardial infarction, and repeat target lesion revascularization (TLR) prior to index hospitalization discharge (< 1 year from procedure)
- MACE [ Time Frame: 1 year ]1-year composite clinical outcome of MACE among all subjects undergoing attempted CTO revascularization that are enrolled in the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946724
|United States, Georgia|
|Piedmont Heart Institute|
|Atlanta, Georgia, United States, 30309|
|Principal Investigator:||David Kandzari, MD||Piedmont Heart Institute|