Optical Coherence TomographyNCT03574636
OCT vs IVUS vs QCA to Guide Moderate-to-severe Calcified Lesion Stent Implantation
A study testing OCT guidance, IVUS guidance and QCA in people with Optical Coherence Tomography and Intravascular Ultrasound, run by Shanghai MicroPort Medical (Group) Co., Ltd. at 1 site in China.
Trial summary
This study is a prospective, multi-center, randomized controlled clinical trial, aims to assess the safety and effectiveness of Optical Coherence Tomography or Intravascular Ultrasound or Quantitative Coronary Analysis to guide Firehawk stent implantation , and compared the treatment of moderate-to-severe calcified… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Optical Coherence Tomography, Intravascular Ultrasound, Angiography
- What is being tested?
- OCT guidance, IVUS guidance and QCA
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2019to Sep 2025
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be 18 to 80 years age
- Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed;
- Subject is eligible for percutaneous coronary intervention (PCI);
- Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia (including NST-ACS, stable CAD and STEMI（duration over 4 weeks）);
- Subjects are eligible candidates for coronary artery bypass graft surgery (CABG);
- Left ventricular ejection fraction (LVEF) detected by cardiac ultrasound within 30 days ≥ 30%;
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- Subject is willing to comply with all protocol-required follow-up evaluation.
- Angiographic Inclusion Criteria (visual estimate):
- The target lesion must be a new lesion and has moderate-to-severe calcification which located in a visually estimated reference diameter ≥2.5 mm and ≤4.0 mm in native coronary artery;
- Target lesion diameter stenosis ≥70% and ≤99%
- Target lesion length ≤70mm
- Judgment of moderate-to-severe calcification:
- Grade II (moderate) calcification:
- Before angiography with or without contrast agent injected, the opacity and deformation of coronary artery can be basically seen, the contour of coronary artery can be basically seen and the contrast agent can fully cover the opacity of blood vessel
- Grade III (severe) calcification:
- Before angiography with or without contrast agent injected, the opacity and deformation of coronary artery can be basically seen, the contour of coronary artery is clearly visible and the contrast agent can partially cover the opacity of blood vessel
- Grade IV (extremely severe) calcification:
- Before angiography with or without contrast agent injected, the opacity of coronary artery can be clearly seen, the contour and deformation are completely visible, and whether the contrast agent is injected is not highly correlated with the changes in the opacity density of blood vessel.
Who cannot join
- Subjects recently suffer from STEMI (within 4 week), and ECG changes/clinical symptoms consistent with AMI or accompanied with increased cardiac biomarkers (CK-MB, CK, TNT or TNI) , and if any of the following criteria is meet in the procedure, patients are excluded; CK-MB> 2ULN, regardless of the value of total CK; total CK> 2ULN, CK-MB or Tn is abnormal;
- If CK-MB or CK was not detected, but cTN> 1ULN, and at least one of the following:
- schemic symptoms and ECG changes of new ischemia; Development of pathologic Q waves in the ECG; Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
- Subject with hemodynamic instability or severely decreased activity tolerance (KILLIP classification >2 or NYHA classification >2 );
- Severely ejection fraction reduced heart failure ( LVEF < 30%)
- Subjects were detected ventricular aneurysm greater than 3.0*2.0cm or intraventricular thrombosis by cardiac ultrasonography in 30 days;
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- Subjects had an organ transplant or are waiting for an organ transplant;
- Subjects are receiving chemotherapy or will receive a chemotherapy within 30 days after PCI;
- Subjects are undergoing chronic (over 72 hours) anticoagulant therapy (such as heparin and coumarin) other than acute coronary syndrome;
- Subjects have confirmed or suspected liver disease, including hepatitis lab results;
- Subjects with elevated serum creatinine level >3.0mg/dL or undergoing dialysis therapy
- Subjects with active peptic ulcer, active gastrointestinal (GI) bleeding or other bleeding diathesis or coagulopathy, or refused a blood transfusion;
- Subjects with cerebral vascular accident (CVA) or transient ischemic attack (TIA) in the past 6 months, or with permanent nerve defects;
- Subjects had any PCI (such as balloon angioplasty, stent, cutting balloon,atherectomy) treatment in target vessels (including collateral) within 13 months prior to baseline;
- Within10mm proximal or distal to the target lesion (including branch artery) had received any PCI prior to baseline;
- Non target vessel had got any PCI in 24 hours prior to baseline;
- Subjects plan to undergo PCI or CABG in 13 months after the baseline PCI;
- Subjects have any coronary endovascular brachytherapy treatment previously;
- Subjects associated with drugs allergy (such as sirolimus, or structure-related compounds fluorinated polymers, thiophenepyridine or aspirin);
- Subjects are suffering from other serious illness (such as cancer, congestive heart failure), which may cause drop in life expectancy to less than 13 months;
- Subjects are currently abusing drugs (such as alcohol, cocaine, heroin, etc);
- Subject plan to undergo any operations that may lead to confuse with the programme;
- Subjects were participating in another study of drug or medical device which did not meet its primary endpoint;
- Subjects plan to pregnant within 13 months after baseline;
- Subjects are pregnant or breastfeeding women.
- Angiographic Exclusion Criteria (visual estimate):
- Target lesions with the following criteria:
- More than 2 target vessel and 2 target lesion Left main Ostial lesion Bifucation lesion( stenosis >70%), branch vessel diameter ≥2.5 mm and lesion length more than 5mm Target lesion located in saphenous vein grafts or arterial grafts Via saphenous vein grafts or arterial graft to treat the target lesion Thrombosis in target lesion Endomembrane tear in target lesion Restenosis in stent prior to the procedure Chronic total occlusion
- Subjects with unprotected left main coronary artery disease (diameter stenosis >50%);
- Subjects have a protected left main coronary artery disease (diameter stenosis> 50% and left coronary artery bypass surgery), as well as target lesions located in the LAD and LCX;
- Subjects with other lesions of clinical significance, may be need intervention within 13 months after baseline.
- Either reason (ig. severe tortuosity, etc) causing stent improperly placed and positioned
Trial locations and contacts
1 site in 1 country.
Yundai Chen, MD contact
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100039
Yundai Chen, Doctor, 13311119778
About this study
Official title: Optical Coherence Tomography Compared With Intravascular Ultrasound or Quantitative Coronary Analysis to Guide Stent Implantation in the Treatment of Moderate-to-severe Calcified Lesion in Coronary Artery
This study is a prospective, multi-center, randomized controlled clinical trial, aims to assess the safety and effectiveness of Optical Coherence Tomography or Intravascular Ultrasound or Quantitative Coronary Analysis to guide Firehawk stent implantation , and compared the treatment of moderate-to-severe calcified lesion in coronary artery.
Read the detailed description
This clinical trial will enroll 375 subjects and assign to groups in a 1:1:1 ratio (base on Intravascular Ultrasound [IVUS]-guided treatment group : Optical Coherence Tomography [OCT]-guided treatment group : Quantitative Coronary Angiography [QCA]-guided treatment group) who have moderate-severe calcified lesions in de novo native coronary artery with ≥2.50 mm to ≤4.00 mm in diameter (visual measurement) from a maximum of 25 study sites in China. After the stent is implanted satisfactorily, OCT examinations will be performed on the subjects of these three groups to observe stent expansion after implantation. At 13 months after procedure, all subjects will receive QCA examination.
OCT sub-group study: The initial 66 ongoing subjects from the three treatment groups (IVUS-guided treatment group : OCT-guided treatment group : QCA-guided treatment group) who provided informed consent and successfully randomized will receive OCT examinations at three months follow up after baseline procedure.
- Being tested
- OCT guidance, IVUS guidance, QCA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT guidanceDevice
OCT guide stent implantation
IVUS guidanceDevice
IVUS guide stent implantation
QCADevice
QCA guide stent implantation
| Study group | Role | What they receive |
|---|---|---|
| OCT guidance | Active comparator | Firehawk stent implantation will be performed with Optical Coherence Tomography guidance.
At the end of the procedure, a final DSA imaging run and OCT measurement must be performed.
At 13-month follow-up, DSA imaging run must be performed. At 3-month follow-up, OCT imaging run must be performed in the first 66 consecutive patients. Receives: Device: OCT guidance |
| IVUS guidance | Active comparator | Firehawk stent implantation will be performed with Intravascular Ultrasound guidance.
At the end of the procedure, a final DSA imaging run and OCT measurement must be performed.
At 13-month follow-up, DSA imaging run must be performed. At 3-month follow-up, OCT imaging run must be performed in the first 66 consecutive patients. Receives: Device: IVUS guidance |
| QCA guidance | Active comparator | Firehawk stent implantation will be performed with Intravascular Ultrasound guidance.
At the end of the procedure, a final DSA imaging run and OCT measurement must be performed.
At 13-month follow-up, DSA imaging run must be performed. At 3-month follow-up, OCT imaging run must be performed in the first 66 consecutive patients. Receives: Device: QCA |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-stent late loss
the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 13 months after the procedure
Measured: 13 months
Secondary outcomes (2)
instant Minimum Stent Area (MSA)
instant Minimum Stent Area (MSA) measured by Optical Coherence Tomography (OCT) during PCI procedure
Measured: during PCI procedure
stent neointimal thickness
stent neointimal thickness at 3 months measured by Optical Coherence Tomography (OCT)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start18 Oct 2019
- Primary completionSep 2021 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optical Coherence TomographyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yundai Chen, MD, Principal investigator, The General Hospital of People's Liberation Army(301 hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574636
- Sponsor's protocol ID
- TARGET 3C
- Status last verified
- Jan 2020
- First submitted
- 20 Jun 2018
- Last updated
- 13 Jan 2020
- 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 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Compared With Intravascular Ultrasound or Quantitative Coronary Analysis to Guide Stent Implantation in the Treatment of Moderate-to-severe Calcified Lesion in Coronary Artery
- ClinicalTrials.gov ID
- NCT03574636
- Acronym / sponsor ID
- TARGET 3C
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 2 Jul 2018 (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 is a prospective, multi-center, randomized controlled clinical trial, aims to assess the safety and effectiveness of Optical Coherence Tomography or Intravascular Ultrasound or Quantitative Coronary Analysis to guide Firehawk stent implantation , and compared the treatment of moderate-to-severe calcified lesion in coronary artery.
Detailed description
This clinical trial will enroll 375 subjects and assign to groups in a 1:1:1 ratio (base on Intravascular Ultrasound [IVUS]-guided treatment group : Optical Coherence Tomography [OCT]-guided treatment group : Quantitative Coronary Angiography [QCA]-guided treatment group) who have moderate-severe calcified lesions in de novo native coronary artery with ≥2.50 mm to ≤4.00 mm in diameter (visual measurement) from a maximum of 25 study sites in China. After the stent is implanted satisfactorily, OCT examinations will be performed on the subjects of these three groups to observe stent expansion after implantation. At 13 months after procedure, all subjects will receive QCA examination.
OCT sub-group study: The initial 66 ongoing subjects from the three treatment groups (IVUS-guided treatment group : OCT-guided treatment group : QCA-guided treatment group) who provided informed consent and successfully randomized will receive OCT examinations at three months follow up after baseline procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| OCT guidance | Active comparator | Device: OCT guidanceFirehawk stent implantation will be performed with Optical Coherence Tomography guidance. At the end of the procedure, a final DSA imaging run and OCT measurement must be performed. At 13-month follow-up, DSA imaging run must be performed. At 3-month follow-up, OCT imaging run must be performed in the first 66 consecutive patients. |
| IVUS guidance | Active comparator | Device: IVUS guidanceFirehawk stent implantation will be performed with Intravascular Ultrasound guidance. At the end of the procedure, a final DSA imaging run and OCT measurement must be performed. At 13-month follow-up, DSA imaging run must be performed. At 3-month follow-up, OCT imaging run must be performed in the first 66 consecutive patients. |
| QCA guidance | Active comparator | Device: QCAFirehawk stent implantation will be performed with Intravascular Ultrasound guidance. At the end of the procedure, a final DSA imaging run and OCT measurement must be performed. At 13-month follow-up, DSA imaging run must be performed. At 3-month follow-up, OCT imaging run must be performed in the first 66 consecutive patients. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Subject must be 18 to 80 years age
- Subject (or legal guardian) understands the trial requirements and the treatment procedures and provides written informed consent before any trial-specific tests or procedures are performed;
- Subject is eligible for percutaneous coronary intervention (PCI);
- Subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia (including NST-ACS, stable CAD and STEMI（duration over 4 weeks）);
- Subjects are eligible candidates for coronary artery bypass graft surgery (CABG);
Key exclusion criteria (32 listed)
- Subjects recently suffer from STEMI (within 4 week), and ECG changes/clinical symptoms consistent with AMI or accompanied with increased cardiac biomarkers (CK-MB, CK, TNT or TNI) , and if any of the following criteria is meet in the procedure, patients are excluded; CK-MB> 2ULN, regardless of the value of total CK; total CK> 2ULN, CK-MB or Tn is abnormal;
- schemic symptoms and ECG changes of new ischemia; Development of pathologic Q waves in the ECG; Imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.
- Subject with hemodynamic instability or severely decreased activity tolerance (KILLIP classification >2 or NYHA classification >2 );
- Severely ejection fraction reduced heart failure ( LVEF < 30%)
- Subjects were detected ventricular aneurysm greater than 3.0*2.0cm or intraventricular thrombosis by cardiac ultrasonography in 30 days;
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 |
|---|---|---|
| OCT guidanceOCT guide stent implantation | Device | OCT guidance |
| IVUS guidanceIVUS guide stent implantation | Device | IVUS guidance |
| QCAQCA guide stent implantation | Device | QCA guidance |
Primary outcome
in-stent late loss
Time frame: 13 months
the difference between the minimal lumen diameter immediately after stent implantation and the minimal lumen diameter by angiography review 13 months after the procedure
2 secondary outcomes
instant Minimum Stent Area (MSA)
Time frame: during PCI procedure
stent neointimal thickness
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
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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.
Yundai Chen, MD contact
Yundai Chen, MD principal investigator
The General Hospital of People's Liberation Army(301 hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT guidance, IVUS guidance and QCA in people with Optical Coherence Tomography and Intravascular Ultrasound, run by Shanghai MicroPort Medical (Group) 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 18 inclusion and 32 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: status not confirmed, as of the sponsor's last update on 13 Jan 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ming Zheng, MD ((86)(21)38954600-6229, mzheng@microport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in-stent late loss (time frame: 13 months). 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 13 Jan 2020.