Chronic Total Occlusion of Coronary ArteryCRUISE-CTONCT04944615
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.
A study testing The guidewire successfully passed the CTO lesion in people with Chronic Total Occlusion of Coronary Artery, run by CCRF Inc., Beijing, China at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Total Occlusion of Coronary Artery
- What is being tested?
- The guidewire successfully passed the CTO lesion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,448 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2022to Oct 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 23Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Being tested
- The guidewire successfully passed the CTO lesion
- Keywords
- TIMI flow = grade 0 coronary artery disease with a duration greater than 3 months.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The guidewire successfully passed the CTO lesionProcedure or surgery
Also called Load dose administration
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: The guidewire successfully passed the CTO lesion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events
All causes of death, myocardial infarction, stent thrombosis (ARC clear/probable), and clinically driven target vessel revascularization
Measured: 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
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.
Measured: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
Nonfatal myocardial infarction
Nonfatal myocardial infarction
Measured: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
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.
Measured: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
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
Measured: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
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
Measured: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
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
Measured: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
Left ventricular function improved
Left ventricular ejection fraction at 1 year and changes from baseline to 1 year
Measured: Baseline period and one-year follow-up period
Percentage stenosis of segmental and stent diameter
Anangiographic percentage of insegment and instent diameter stenosis measured by QCA at 12 months postoperatively
Measured: The follow-up period was 12 months
Lumens in segmental vessels and stents were lost
12 months postoperatively, angiographic measurements of intrasegmental and in-stent lumens by QCA were lost
Measured: The follow-up period was 12 months
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
Measured: The follow-up period was 12 months
Minimum lumen diameters in segments and stents
Minimum lumen diameters in segmental vessels and stents as measured by QCA 12 months postoperatively
Measured: The follow-up period was 12 months
QCA measurements were obtained immediately in the lumen
Immediate luminal measurements of QCA during surgery were obtained
Measured: Baseline operative period
MLD measured by QCA
MLD measured by QCA during surgery
Measured: Baseline operative period
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
Measured: Baseline operative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start21 Oct 2022
- Primary completionOct 2031 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Total Occlusion of Coronary ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 1,448 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CCRF Inc., Beijing, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BSC International Medical Trading (Shanghai) Co., Ltd.
- Responsible party
- Principal investigator, Yaling Han, M.d., Ph.D., General Hospital of Shenyang Military Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04944615
- Acronym
- CRUISE-CTO
- Status last verified
- Oct 2026
- First submitted
- 1 Jun 2021
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04944615
- Acronym / sponsor ID
- CRUISE-CTO
- Keywords
- TIMI flow = grade 0 coronary artery disease with a duration greater than 3 months.
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,448 participants (estimated)
- Lead sponsor
- CCRF Inc., Beijing, ChinaIndustry (pharma, biotech, devices)
- Collaborators
- BSC International Medical Trading (Shanghai) Co., Ltd.
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- Oct 2031 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intravascular ultrasound guidance | Experimental | Procedure: The guidewire successfully passed the CTO lesionAll 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. |
| Angiographic guidance | Active comparator | Procedure: The guidewire successfully passed the CTO lesionThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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
- Pregnant and lactating women
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The guidewire successfully passed the CTO lesionAlso: Load dose administrationThe 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. | Procedure or surgery | Angiographic guidance, Intravascular ultrasound guidance |
Primary outcome
Major adverse cardiac events
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.
All causes of death, myocardial infarction, stent thrombosis (ARC clear/probable), and clinically driven target vessel revascularization
14 secondary outcomes
Cardiogenic death
Time frame: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
Nonfatal myocardial infarction
Time frame: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
Target lesion revascularization
Time frame: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
Target vessel revascularization
Time frame: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
Target lesion failure
Time frame: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
Target vessel failure
Time frame: 30 days, 6 months, 12 months, 24 months, 36 months, 48 months after surgery
Left ventricular function improved
Time frame: Baseline period and one-year follow-up period
Percentage stenosis of segmental and stent diameter
Time frame: The follow-up period was 12 months
Lumens in segmental vessels and stents were lost
Time frame: The follow-up period was 12 months
Binary restenosis rate in segment and stent
Time frame: The follow-up period was 12 months
Minimum lumen diameters in segments and stents
Time frame: The follow-up period was 12 months
QCA measurements were obtained immediately in the lumen
Time frame: Baseline operative period
MLD measured by QCA
Time frame: Baseline operative period
Clinical success rate
Time frame: Baseline operative period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The guidewire successfully passed the CTO lesion in people with Chronic Total Occlusion of Coronary Artery, run by CCRF Inc., Beijing, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.