Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04965207
Other study ID # LAOHUOJI
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date October 1, 2021
Est. completion date December 31, 2025

Study information

Verified date September 2021
Source Shanghai 10th People's Hospital
Contact Hu Tao, M.D.
Phone 13363999556
Email dr_ht556@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1000
Est. completion date December 31, 2025
Est. primary completion date December 31, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Chronic Total Occlusion of Coronary Artery

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Shanghai 10th People's Hospital Xijing Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Late Lumen Loss Late Lumen Loss was defined as the difference between post-stenting minimal lumen diameter (MLD) minus MLD at the time of follow-up. 1 year after PCI
Secondary Late Lumen Loss Late Lumen Loss was defined as the difference between post-stenting minimal lumen diameter (MLD) minus MLD at the time of follow-up. 3 year after PCI
Secondary Major Adverse of Cardiovascular and Cerebrovascular Events(MACCE) including any of the following adverse events before hospital discharge: death from any cause, Q-wave myocardial infarction, recurrent symptoms Heart and Vessels requiring urgent repeat target vessel revascularization with PCI or CABG, tamponade requiring either pericardiocentesis or surgery, and stroke. Within the first week after PCI, at the 1-year follow-up and at the 3-year follow-up
Secondary Complications Any periprocedural complication was defined as the composite of death, myocardial infarction, stent thrombosis, stroke, vessel perforation, vascular access complications, need for emergency surgical intervention or PCI, and hemoglobin reduction by >3 g/dL. Within the first week after PCI
See also
  Status Clinical Trial Phase
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Completed NCT03475888 - Incidence of Ventricular Arrhythmias in Patients With Chronic Total Occlusion Recanalization N/A
Not yet recruiting NCT04917432 - Early and Midterm Outcomes of Intravascular Ultrasound (IVUS) Versus Non-IVUS Guidance in Complex Coronary Chronic Total Occlusion (CTO) Revascularization. N/A
Recruiting NCT04944615 - To Evaluate Whether IVUS-guided Drug-eluting Stent (DES) Implantation Leads to Better Clinical Outcomes Compared to Conventional Angiography in the Treatment of Chronic Complete Occlusion (CTO) Disease. N/A
Completed NCT01861860 - OPtimized Stenting Using Intravascular Ultrasound(IVUS) in Long lEsion: Rationale for Simplified criteriA N/A
Recruiting NCT05142215 - A Placebo-controlled Trial of Chronic Total Occlusion Percutaneous Coronary Intervention for the Relief of Stable Angina N/A
Active, not recruiting NCT05464147 - DYNAMX Bioadaptor ImplanTation for the trEatment of Complex Coronary Lesions N/A
Recruiting NCT04145167 - Observational Registry on Clinical Outcome After Diagnosis of Chronic Total Occlusions
Active, not recruiting NCT05197361 - Microvascular Coronary Resistance and Absolute Coronary FLOW in Patients With Percutaneous Intervention of a Chronic Total Occlusion
Recruiting NCT05813704 - Coronary Crossing System in Patients With Coronary Chronic Total Occlusions N/A
Recruiting NCT03563417 - ISCHEMIA-CTO Trial - Revascularisation or Optimal Medical Therapy of CTO N/A
Completed NCT05377866 - Holo CTO Proctoring Study
Completed NCT01978860 - A Prospective, First in Man Study to Evaluate the Safety and Performance of the NovaCross™ Micro-catheter N/A
Withdrawn NCT02784418 - The SHINE-CTO Trial N/A
Completed NCT03988166 - Chronic Total Occlusion Percutaneous Coronary Intervention Study N/A
Completed NCT02477579 - A Prospective, Multi-Center, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions N/A
Completed NCT03209843 - Post-stenting Assessment of Reendothelialization With OFDI After CTO Procedure (PERFECTO) N/A
Completed NCT03947398 - The BLIMP Balloon in Coronary Interventions N/A
Active, not recruiting NCT04060615 - Properties of Myocardial Microcirculation in Patients With Different Pathomorphological Substrates, Before and After Recanalization of Coronary Artery CTO N/A
Terminated NCT03118544 - REduction of Contrast Via DyeVert Used in CTO Procedures