EvaLuAtion On the cHaracteristics of the True/False lUmen... | NCT04965207

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

NCT04965207

Sponsor

Shanghai 10th People's Hospital

Status

Unknown status

Last Update Posted

Sep 28, 2021Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Chronic Total Occlusion of Coronary Artery

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2021Estimated

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2025Estimated

First Submitted Date

Jul 11, 2021

First Submission Date that Met QC Criteria

Jul 15, 2021

First Posted Date

Jul 16, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 25, 2021

Last Update Posted Date

Sep 28, 2021Actual

Name	Class
Xijing Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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
Major Adverse of Cardiovascular and Cerebrovascular Events(MACCE)

Other Outcomes

Not provided

Eligibility Module

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.](streamdown:incomplete-link)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing CTO PCI at each of the participating centers

Sampling Method

Non-Probability Sample