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. - Clinical Trial for Chronic Total Occlusion of Coronary Artery | NCT04944615

Back to results

Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

The guidewire successfully passed the CTO lesion

About this trial

This is an interventional other trial for Chronic Total Occlusion of Coronary Artery focused on measuring TIMI flow = grade 0 coronary artery disease with a duration greater than 3 months.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Clinical inclusion criteria:

At least 18 years old
Subjects will understand the test requirements, treatment and surgery, and can provide written informed consent
Subjects with clinical symptoms of ischemic heart disease or evidence of myocardial ischemia associated with CTO target vessels and scheduled to undergo Percutaneous coronary intervention (PCI)
Subjects will receive percutaneous coronary intervention
Subjects are willing to accept all treatment and follow-up evaluations required by the protocol

Inclusion criteria for angiography:

Primary coronary artery CTO lesion with visible collateral circulation
Estimation of the time to complete occlusion (TIMI grade 0) ≥3 months based on clinical history and/or comparison with historical angiography or ECG
It is suitable for target lesions of 2.25-4.0mm stent implantation
The length of CTO lesion should be greater than 20mm

Clinical exclusion criteria:

Pregnant and lactating women
Severe coronary artery disease, not suitable for PCI
Patients with acute myocardial infarction less than 7 days
Long-term contraindications to DAPT (at least 1 year)
Known renal insufficiency.20 mL/min / 1.73 ㎡)
Left ventricular ejection fraction <35% or cardiogenic shock
The ICD implanted/CRT
Severe bleeding or stroke within 6 months
Have a history of allergy to iodine contrast agents or any known allergy to clopidogrel, ticagrelor, aspirin, or heparin
Subjects have been diagnosed or suspected of liver disease, including laboratory evidence of hepatitis
Valvular heart disease significantly affecting hemodynamics, hypertrophic cardiomyopathy, restrictive cardiomyopathy, or congenital heart disease
Diseases that researchers believe may seriously harm patients, such as cancer and mental illness;Or the patient's life expectancy is less than one year and the follow-up cannot be completed;Or other conditions that researchers think might have confounded the results
Participate in any other ongoing trial or intend to participate in another clinical trial of a drug or device within 12 months after baseline surgery

Angiographic exclusion criteria:

The target lesion is located in the left main artery
No visible collateral circulation in CTO lesions
Target lesion is venous or arterial bypass graft
The target vessel occlusion time (TIMI grade 0) < 3 months can be determined

Sites / Locations

General Hospital of Shenyang Military RegionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intravascular ultrasound guidance

Angiographic guidance

Arm Description

All targeted CTO lesions will be examined and documented using a commercially available IVUS catheter (Opticross HD) according to its instructions (if not contraindicated, preoperative vasodilation with nitroglycerin to prevent spasm). IVUS examination must be performed at least once before and after stent implantation.

The patient will choose the appropriate length and diameter of the stent to be implanted by visual estimation. All commercially available drug-eluting stents (except first-generation DES, such as Taxus, Excel, Partner, Firebird, etc.) can be used. DES with high quality clinical evidence is strongly recommended. The type, diameter, and length of the stent are determined by the surgeon. The stent length should be selected to ensure complete coverage of the CTO lesion. If dissection is present, additional stents are implanted. Repeat angiograms were performed immediately after surgery in the same view as before surgery.

Outcomes

Primary Outcome Measures

Major adverse cardiac events

All causes of death, myocardial infarction, stent thrombosis (ARC clear/probable), and clinically driven target vessel revascularization

Secondary Outcome Measures

Cardiogenic death

This includes acute myocardial infarction, cardiac perforation/tamponade, arrhythmia or conduction abnormalities, cerebrovascular accidents at discharge or suspected operating-related cerebrovascular accidents, death from surgical complications, including hemorrhage, vascular repair, transfusion reaction, or bypass surgery, or any death of cardiac origin that cannot be ruled out.

Nonfatal myocardial infarction

Target lesion revascularization

Target lesion revascularization is any ischemia-driven repetitive percutaneous coronary intervention to improve blood flow to a successfully treated target lesion or to bypass the target vessel and use a graft distally to the successfully treated target lesion. If the target lesion diameter is ≥50% stenosis as assessed by QCA and there is clinical or functional ischemia that cannot be explained by other coronary or graft lesions, vascularization will be considered to be induced by ischemia.

Target vessel revascularization

Target vessel revascularization is defined as repeated intervention in the vessel where the target lesion is located in reference to target lesion revascularization

Target lesion failure

Target lesion failure refers to target lesion revascularization, target vascular-related MI (Q wave and non-Q wave) or (cardiac) death due to ischemia

Target vessel failure

Target vessel failure refers to target vessel revascularization, target-related MI (Q wave and non-Q wave), or target-related (cardiac) death resulting from ischemia

Left ventricular function improved

Left ventricular ejection fraction at 1 year and changes from baseline to 1 year

Percentage stenosis of segmental and stent diameter

Anangiographic percentage of insegment and instent diameter stenosis measured by QCA at 12 months postoperatively

Lumens in segmental vessels and stents were lost

12 months postoperatively, angiographic measurements of intrasegmental and in-stent lumens by QCA were lost

Binary restenosis rate in segment and stent

Binary restenosis refers to the previously treated stenosis diameter at the lesion site > 50%, including the original treatment area and proximal and distal areas adjacent to the QCA analysis segment

Minimum lumen diameters in segments and stents

Minimum lumen diameters in segmental vessels and stents as measured by QCA 12 months postoperatively

QCA measurements were obtained immediately in the lumen

Immediate luminal measurements of QCA during surgery were obtained

MLD measured by QCA

MLD measured by QCA during surgery

Clinical success rate

Clinical success was defined by visual evaluation of mean lesion diameter stenosis by the physician on 2 near-orthogonal projection angiography with TIMI blood flow grade 3. No nosocomial myocardial infarction, TVR or cardiac death occurred in 30% of patients

Full Information

NCT ID

NCT04944615

First Posted

June 1, 2021

Last Updated

March 27, 2023

Sponsor

CCRF Inc., Beijing, China

Collaborators

BSC International Medical Trading (Shanghai) Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04944615

Brief Title

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.

Acronym

CRUISE-CTO

Official Title

IVUS-CTO: Comparison of the Effect of Intravascular Ultrasound-guided Versus Angiographic-guided Drug-eluting Stent Implantation on Long-term Clinical Outcomes in Patients With Chronic Complete Occlusion of Coronary Artery Disease: a Prospective, Multicenter, Randomized Controlled Clinical Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 21, 2022 (Actual)

Primary Completion Date

October 2031 (Anticipated)

Study Completion Date

October 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

CCRF Inc., Beijing, China

Collaborators

BSC International Medical Trading (Shanghai) Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study aims to evaluate the treatment of Chronic total occlusion (CTO) disease. Whether Intravascular Ultrasonography (IVUS) guiding the implantation of drug-eluting stents (DES) will provide better long-term clinical outcomes compared with conventional angiography

Detailed Description

The study was a prospective, multicenter, open-label, two-arm, 1:1 randomized controlled, well-designed clinical study. According to the sample size calculation, a total of 1448 patients with primary CTO lesions were required to participate in the study after the guide wire successfully passed through the lesion (defined as: angiographic indication that the guide wire successfully passed through the CTO lesion and reached the distal true lumen). The study will be conducted at no more than 45research centers. With competitive enrolment, a maximum of 500 patients can be enrolled at each center or until the study is completed, whichever comes first. It is recommended that each center enroll at least 20 patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Total Occlusion of Coronary Artery

Keywords

TIMI flow = grade 0 coronary artery disease with a duration greater than 3 months.

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Patients were enrolled when the guide wire successfully passed through the CTO lesion (defined as: the guide wire successfully passed through the CTO lesion and reached the distal true lumen as confirmed by angiography). Once patients have signed the informed consent form and met all clinical and angiographic inclusion criteria and did not meet all clinical and angiographic exclusion criteria, and the guide wire has successfully passed the CTO lesion, they may be considered for participation in the study and randomized. The random grouping arrangement is computer generated using a quasi-random number generator. All randomized subjects will be assigned a unique identification number. Randomized replacement blocks will be used to ensure that the distribution of treatment within each layer is approximately balanced. The study also used the Interactive Voice Response System (IVRS)/Interactive Internet Response System (IWRS) to assign subjects to the study device treatment group.

Masking

None (Open Label)

Masking Description

During the study, it is difficult for researchers, operators and patients to blind the method due to objective reasons.

Allocation

Randomized

Enrollment

1448 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intravascular ultrasound guidance

Arm Type

Experimental

Arm Description

All targeted CTO lesions will be examined and documented using a commercially available IVUS catheter (Opticross HD) according to its instructions (if not contraindicated, preoperative vasodilation with nitroglycerin to prevent spasm). IVUS examination must be performed at least once before and after stent implantation.

Arm Title

Angiographic guidance

Arm Type

Active Comparator

Arm Description

The patient will choose the appropriate length and diameter of the stent to be implanted by visual estimation. All commercially available drug-eluting stents (except first-generation DES, such as Taxus, Excel, Partner, Firebird, etc.) can be used. DES with high quality clinical evidence is strongly recommended. The type, diameter, and length of the stent are determined by the surgeon. The stent length should be selected to ensure complete coverage of the CTO lesion. If dissection is present, additional stents are implanted. Repeat angiograms were performed immediately after surgery in the same view as before surgery.

Intervention Type

Procedure

Intervention Name(s)

The guidewire successfully passed the CTO lesion

Other Intervention Name(s)

Load dose administration

Intervention Description

The successful passage of the guide wire through the CTO lesion was defined as: the guide wire successfully passed through the CTO lesion and reached the distal true lumen as confirmed by angiography. Aspirin load dose (300 mg), clopidogrel load dose (300 mg), or ticagrelor load dose (180 mg) is recommended for all subjects prior to stent implantation and is recommended to be taken at least 6 hours prior to surgery.

Primary Outcome Measure Information:

Title

Major adverse cardiac events

Description

All causes of death, myocardial infarction, stent thrombosis (ARC clear/probable), and clinically driven target vessel revascularization

Time Frame

The study design was event-driven. When a predetermined number of primary endpoints (number of MACE events = 291) occurs (expected 3 years), the study termination procedure will be initiated and this data will be used for primary end point analysis.

Secondary Outcome Measure Information:

Title

Cardiogenic death

Description

This includes acute myocardial infarction, cardiac perforation/tamponade, arrhythmia or conduction abnormalities, cerebrovascular accidents at discharge or suspected operating-related cerebrovascular accidents, death from surgical complications, including hemorrhage, vascular repair, transfusion reaction, or bypass surgery, or any death of cardiac origin that cannot be ruled out.

Time Frame