Ultrasonic Cardiogram Evaluate the Prognosis of Percutaneous Revascularization of Chronic Total Occlusions
Ultrasonic Cardiogram to Evaluate the Long-term Outcome and Prognosis of Coronary Artery Chronic Total Occlusions for Percutaneous Revascularization Versus Optimal Medical Treatment
1 other identifier
interventional
200
1 country
1
Brief Summary
Chronic total occlusions (CTO) are encountered in almost one-fourth of patients undergoing coronary angiography. The presence of an untreated CTO has been related to adverse clinical prognosis, both in stable angina and acute myocardial infarction, and is often associated with persistent symptomatic angina. Depending on their symptomatic and functional status as well as anatomical complexity, CTO can be treated by optimal medical therapy only or therapy combined with coronary revascularization. This study designed to evaluate the safety and efficacy of coronary chronic total occlusion PCI by ultrasonic cardiogram.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 27, 2017
CompletedFirst Posted
Study publicly available on registry
October 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedOctober 3, 2017
September 1, 2017
2 years
September 27, 2017
October 2, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
cardiac death,
patients with CTO postoperative sudden death cause for acute myocardial infarction or severe arrhythmia
postoperation 1year
MACE
recurrent severe angina, revascularization
postoperation 1year
Study Arms (3)
recanalisation CTO lesion successful
EXPERIMENTALPatients with CTO lesion performed PCI strategy and successfully recanalisation the CTO lesion with implanted stents .
recanalisation CTO lesion failure
NO INTERVENTIONPatients with CTO lesion performed PCI strategy and failure recanalisation the CTO lesion with PCI wire and balloon..
OMT
NO INTERVENTIONPatients with CTO lesion optimal medicine treatment without PCI
Interventions
Eligibility Criteria
You may qualify if:
- coronary artery of chronic total occlusion
You may not qualify if:
- ACS in 3months; once PCI or CABG; AF
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongda Hospital
Nanjing, Jiangsu, 210009, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- masking for Ultrasonic Cardiogram investigator
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
September 27, 2017
First Posted
October 3, 2017
Study Start
October 1, 2016
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
October 3, 2017
Record last verified: 2017-09
Data Sharing
- IPD Sharing
- Will not share