AzTrials
AzTrials

Chronic Total Occlusion of Coronary ArteryVITALNCT05813704

Coronary Crossing System in Patients With Coronary Chronic Total Occlusions

A study testing Coronary Crossing System of Shanghai MicroPort Rhythm in people with Chronic Total Occlusion of Coronary Artery, run by Shanghai MicroPort Rhythm MedTech Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary crossing system for the treatment of patients with coronary chronic total occlusions. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Coronary Crossing System of Shanghai MicroPort Rhythm
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
159 participants
Where
1 siteChina
Study dates
7 Nov 2023to 19 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

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

  • Clinical Inclusion Criteria:
  • Aged 18 years and older.
  • Subjects with coronary artery disease who have symptoms of angina pectoris and evidence of ischemia or myocardial viability in the area innervated by the coronary arteries where the CTO is located.
  • Subjects who are able to understand the purpose of the trial, participate voluntarily or by proxy and indicate by signing the informed consent form that they recognize the risks and benefits described in the informed consent document and are willing to undergo clinical follow-up.
  • Angiography Inclusion Criteria:
  • There is only one target CTO that needs to be treated with percutaneous coronary intervention (PCI).
Show all 13Show fewer
  • Target CTO is located in a native coronary artery with a reference vessel diameter of ≥ 2.5 mm.
  • Angiography showed complete occlusion of the target CTO (visual inspection), antegrade flow of the occluded vessel segment TIMI grade 0 and inferred occlusion time ≥ 3 months; or previous angiographic records confirmed occluded time of the target CTO ≥ 3 months.
  • The target CTO occluded segment length ≥ 5 mm (visual inspection).
  • Angiography of the target CTO showed high density along the vessel, which is considered calcified lesion.
  • The antegrade approach is determined as the primary strategy with guidewire crossing in PCI treatment.
  • The fibrous cap of the target lesion can not be penetrated within 60 seconds using the guidewire with polypolymer coated or tip stiffness > 1.5g (visual inspection) under fluoroscopy and the time is timed when the guidewire reaches the fibrous cap. (To identify chronic total occlusions and exclude acute or subacute occlusions that such guidewire can pass directly).
  • In addition to the target lesion, there must be up to one non-target lesion to be treated and it is located on a different epicardial vessel than the target lesion. Target lesions can be treated after successful treatment of the non-target lesion (residual stenosis < 30% and TIMI 3 flow) without complications.

Who cannot join

  • General Exclusion Criteria:
  • Acute myocardial infarction within 30 days prior to baseline procedure.
  • Life expectancy < 1 year.
  • Inability to use protocol-required concomitant medications (eg, aspirin, P2Y12 platelet receptor inhibitors, heparin, contrast agents, etc) due to allergy or other contraindications, and no alternative medications.
  • The target CTO has an iatrogenic dissection that occurred within the past 3 months.
  • Left ventricular ejection fraction less than 35%.
Show all 23Show fewer
  • Severe aortic or mitral valve disease.
  • Planned left ventricular (LV) support device during CTO PCI.
  • Subjects with clear bleeding tendency, contraindications to antiplatelet agents and anticoagulant therapy.
  • Stroke, transient ischemic attack (TIA), or significant gastrointestinal (GI) bleeding within 6 months before the baseline procedure.
  • Planned additional coronary or valvular percutaneous or surgical intervention scheduled within 30 days after baseline procedure.
  • Subjects who require emergent or urgent PCI.
  • Female subjects who are pregnant or breast-feeding.
  • Subjects who are participating in another investigational drug or device clinical trial in which the primary endpoint is still not reached, or intend to participate in another investigational drug or device clinical trial within 12 months after baseline procedure.
  • Other medical illnesses that may cause the subject to be non-compliant with the protocol or confound data interpretation.
  • Serum creatinine > 2.5 mg/dL (or 221 µmol/L), or on dialysis.
  • Hemodynamic instability or severely impaired activity tolerance (KILLIP Class III, IV, or NYHA Class III, IV).
  • Subjects with sustained tachyarrhythmia or cardiogenic shock.
  • Angiography Exclusion Criteria:
  • The target CTO is in an unprotected left main.
  • No angiographically visible collateral flow to the target vessel distal to the occlusion, from ipsilateral or contralateral collaterals.
  • Because of the presence of moderate to severe tortuosity or stenosis in the collateral vessels, retrograde approach is not preferred at the investigator 's discretion.
  • Vessel tortuosity proximal to, or within, body of target occlusion which, in the opinion of the investigator, is not amenable to advancement of a microcatheter or Coronary Crossing System.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongshan Hospital of Fudan University

    Shanghai

Other trials in China

About this study

Official title: A Prospective, Multicenter Clinical Trial in Evaluating the Safety and Efficacy of the Coronary Crossing System in Patients With Coronary Chronic Total Occlusions

This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary crossing system for the treatment of patients with coronary chronic total occlusions.

Read the detailed description

This study is divided into two phases. The first phase is the pilot study stage, which is a prospective single-group observational test (FIM phase). The second phase is the pivotal study phase, which is a prospective, multi-center, single-group clinical trial (OPC phase). It is carried out in about 20 hospitals in China.

  1. Pilot study phase (FIM phase): It is a prospective single-group observational test. It is expected to recruit 10 subjects in a research center in China.
  2. Pivotal study phase (OPC phase): It is a prospective, multicenter, single-group clinical trial. 146 subjects are expected to be recruited in 20 research centers in China.
  3. All subjects with coronary chronic total occlusions participating in this clinical study must have only a CTO lesion which occluded in length of more than 5 mm and located in a native coronary artery with a diameter of ≥ 2.50 mm (visual inspection).
  4. All subjects receive clinical follow-up during hospitalization, 30 days after surgery.
Being tested
Coronary Crossing System of Shanghai MicroPort Rhythm
Keywords
chronic total occlusions, coronary artery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary Crossing System of Shanghai MicroPort RhythmDevice

    The mechanical vibration generated by the Coronary Crossing System through the piezoelectric effect is amplified and transmitted to the distal end of the guidewire to achieve high-frequency vibration at the tip of the guidewire, and then achieve efficient and safe penetration of the fibrous cap of the CTO.

Study groups in NCT05813704
Study groupRoleWhat they receive
Coronary Crossing SystemExperimentalSubjects in experimental group will be treated with the Coronary Crossing System manufactured by Shanghai Microport Rhythm Co. Ltd.
Receives: Device: Coronary Crossing System of Shanghai MicroPort Rhythm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Device success

    Device success is defined as successful antegrade crossing of the CTO into the true arterial lumen distal to the occlusion following advancement of at least 3 mm of the Coronary Crossing System into any segment as assessed by the core angiographic laboratory.

    (An antegrade only approach may involve Antegrade Dissection Re-Entry (ADR) with or without the use of specialized devices (e.g. Stingray); absence of successful retrograde crossing of a collateral will still be considered an antegrade only approach.)

    Measured: Baseline procedure

Secondary outcomes (6)

  1. Overall device success

    Overall device success is defined as successful crossing of the CTO, following use of the coronary crossing system during the procedure including antegrade or retrograde approach.

    Measured: Baseline procedure

  2. Technical Success

    Technical success is defined as successful antegrade or retrograde crossing of the CTO into the true arterial lumen following advancement of at least 3 mm of the Coronary Crossing System into the proximal segment, with <30% residual stenosis of the CTO after successful treatment with drug-eluting stents or drug-eluting balloons, with antegrade flow≥TIMI grade 2 in all branch vessels ≥ 2.5 mm in diameter distal to the CTO, as assessed by the core angiographic laboratory.

    Measured: Baseline procedure

  3. Procedural Success

    Procedural success is defined as the achievement of Technical Success with freedom from device related MAEs as assessed by the Clinical Events Committee (CEC).

    Measured: Baseline procedure

  4. Clinical Success

    Clinical success is defined as the achievement of Procedural Success with freedom from device related MAEs through 48 hours or hospital discharge and 30 days post index procedure as assessed by the Clinical Events Committee (CEC).

    Measured: 30 days post-procedure

  5. Freedom from device related major adverse event(MAE)

    Freedom from device related major adverse events (MAEs) at 48 hours or hospital discharge (whichever occurs first) post procedure, as assessed by Clinical Events Committee (CEC), defined as:

    • Cardiovascular related deaths
    • Myocardial Infarction.
    • Coronary Artery Perforation requiring treatment
    • Unscheduled cardiac surgery anytime between enrollment to completion of the study.
    • Intra-procedure stroke
    • Radiation exposure ≥ 8 Gy

    Measured: 48 hours or until discharge

  6. Freedom from major adverse event(MAE)

    Freedom from major adverse event(MAE) is defined as the freedom from device related MAE assessed through 30 days post-index procedure, as assessed by the Clinical Events Committee(CEC).

    Measured: 30 days post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2023
  2. Study start7 Nov 2023
  3. Primary completion19 Jul 2024
  4. Study completion19 Aug 2024

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05813704
Sponsor's protocol ID
AMD-D-003
Acronym
VITAL
Status last verified
Aug 2026
First submitted
3 Apr 2023
Last updated
10 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Coronary Crossing System of Shanghai MicroPort Rhythm in people with Chronic Total Occlusion of Coronary Artery, run by Shanghai MicroPort Rhythm MedTech Co., Ltd. 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 13 inclusion and 23 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: finished, as of the sponsor's last update on 10 Aug 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Device success (time frame: Baseline procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05813704.

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 10 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in