Precision Therapy in Complex High-risk Coronary Artery Disease
PTCA
Prospective Registry of the Intracoronary Physiology and Imaging-guided Precision Therapy in Complex High-risk Patients
1 other identifier
observational
1,000
1 country
1
Brief Summary
This is a prospective registry to enroll complex high-risk coronary heart disease patients. The purpose of this study is to compare intracoronary physiology and imaging-guided intervention strategy and angiography-guided intervention strategy for clinical outcomes and health economics.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2020
Typical duration for all trials
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
First Submitted
Initial submission to the registry
June 21, 2020
CompletedFirst Posted
Study publicly available on registry
June 24, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedAugust 21, 2020
August 1, 2020
2.9 years
June 21, 2020
August 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Composite ischemic events
Composite ischemic event is defined as the composite of cardiac death, stent thrombosis, nonfatal myocardial infarction or ischemic driven revascularization.
24 months
Study Arms (2)
Intracoronary physiology and imaging-guided group
Angiography-guided group
Interventions
Intracoronary physiology and imaging-guided intervention strategy versus angiography-guided intervention strategy for complex high-risk coronary heart disease patients
Eligibility Criteria
Coronary heart disease patients with complicated clinical conditions and/or complex coronary lesions.
You may qualify if:
- Bifurcation lesions with branch diameter ≥2.5mm;
- Chronic complete occlusion (occlusion duration ≥3 months);
- Left main disease;
- Long lesions (≥38mm);
- Multi-vessel percutaneous coronary intervention (simultaneous treatment of ≥2 epicardial vessels during one operation);
- Multi-stent implantation (≥3 stents);
- In-stent restenosis;
- Moderate to severe calcification on radiography;
- Intermediate lesion;
- Thrombotic lesions;
- Creatinine clearance rate \< 60ml/min) or on dialysis ;
- Left ventricular ejection fraction \<40% ；
- History of cerebral hemorrhage or massive hemorrhage of gastrointestinal tract.
You may not qualify if:
- Informed consent cannot be obtained;
- Life expectancy \< 1 year.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xin Huang, phD
First Affiliated Hospital Xi'an Jiaotong University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 24 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2020
First Posted
June 24, 2020
Study Start
July 1, 2020
Primary Completion
June 1, 2023
Study Completion
December 1, 2023
Last Updated
August 21, 2020
Record last verified: 2020-08