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.

NCT04944615 | Recruiting DMC

• Study Type: interventional
• Target: 1,448
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Total Occlusion of Coronary Artery

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Major adverse cardiac events

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

  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 Outcomes (14)

• Cardiogenic death

  30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery

• Nonfatal myocardial infarction

  30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery

• Target lesion revascularization

  30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery

• Target vessel revascularization

  30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery

• Target lesion failure

  30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery

Study Arms (2)

Intravascular ultrasound guidance

EXPERIMENTAL

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.

Procedure: The guidewire successfully passed the CTO lesion

Angiographic guidance

ACTIVE COMPARATOR

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.

Procedure: The guidewire successfully passed the CTO lesion

Interventions

The guidewire successfully passed the CTO lesion PROCEDURE

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.

Also known as: Load dose administration

Angiographic guidance; Intravascular ultrasound guidance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• The target lesion is located in the left main artery
• No visible collateral circulation in CTO lesions

Sponsors & Collaborators

• CCRF Inc., Beijing, China: lead
• BSC International Medical Trading (Shanghai) Co., Ltd.: collaborator

Study Sites (1)

General Hospital of Shenyang Military Region

Beijing, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: During the study, it is difficult for researchers, operators and patients to blind the method due to objective reasons.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academician/chief physician

Model Details: 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.

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 29, 2021
• Study Start: October 21, 2022
• Primary Completion (Estimated): October 1, 2031
• Study Completion (Estimated): October 1, 2031
• Last Updated: March 29, 2023

Record last verified: 2023-03

Locations

CN (1)