EvaLuAtion On the cHaracteristics of the True/False lUmen and Its Prognostic Value for cOronary CTO Patients Just Before Stent Implantation

NCT ID: NCT04965207

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2025-12-31

Brief Summary

IVUS will be used to evaluate the ratio of false lumen to occluded segment, the ratio of false lumen to stent length, the location characteristics of false lumen and its prognostic value for perioperative complications, 1-year late lumen loss and MACCE events in patients with coronary CTO.

Detailed Description

At present, novel technologies of CTO interventional therapy become mature. These technologies usually artificially cause dissection of coronary artery. The events such as collateral vessel loss, vascular injury and tear, perforation, pericardial tamponade caused by false lumen may theoretically affect the perioperative and long-term prognosis of patients. In this study, intravascular ultrasound (IVUS) was used to evaluate the characteristics of true lumen and false lumen in CTO segment, so as to determine its impact on the prognosis of patients.

Conditions

Chronic Total Occlusion of Coronary Artery

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 18 to 80 years old;
• be diagnosed with CTO;
• CTO located in an epicardial coronary artery with a reference diameter of ≥ 2.5mm;
• comply with all the evaluations and follow-up protocols.

Exclusion Criteria

• suffered from acute myocardial infarction within the previous 3 months;
• rheumatic valvular disease;
• severe arrhythmia;
• lesions unsuitable for PCI;
• severely abnormal hematopoietic systems, such as platelet counts <100*10^9/L or > 700*10^9/L and white blood cell counts < 3*10^9/L;
• with active bleeding or bleeding tendencies(active ulcers, short-term ischemic stroke, history of hemorrhagic stroke, intracranial space occupying lesions, recent craniocerebral trauma, and other bleeding or bleeding tendency);
• severe coexisting conditions, including severe renal function dysfunction [Glomerular filtration rate less than 60ml/min • 1.73 m2), severe hepatic dysfunction [glutamic-pyruvic transaminase (ALT) or glutamic-oxal acetic transaminase (ALT) elevated more than three times that of the upper limit of the normal reference], severe heart failure (NYHA classification III-IV), acute infectious diseases and immune disorders; tumors; surgery within 3 months;
• a life expectancy less than 12 months;
• pregnancy or planning to become pregnant;
• history of allergy or adverse reactions to aspirin, clopidogrel, ticagrelor, stains, contrast material, anticoagulant, or stents;
• cannot tolerate dual antiplatelet treatment;
• unable to communicate due to cognitive impairment, auditory, or visual impairment;
• participating in another trial for medication or an apparatus and in which the main endpoint has not been reached, or plan to participate in a clinical trial within 12 months of the intervention.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: collaborator

Shanghai 10th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ya-Wei Xu

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Hu Tao, M.D.

Role: CONTACT

dr_ht556@163.com

13363999556

Other Identifiers

LAOHUOJI

Identifier Type: -

Identifier Source: org_study_id