CHD - Coronary Heart DiseaseNCT03809754
Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis
A study testing Percutaneous Coronary Intervention under OCT and Percutaneous Coronary Intervention under Angiography in people with CHD - Coronary Heart Disease and Percutaneous Coronary Intervention, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This study is a prospective, registry trial aimed to compare the clinical and angiographic outcomes of OCT-guided and angiography-guided PCI in patients with coronary DES-ISR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CHD - Coronary Heart Disease, Percutaneous Coronary Intervention, In-stent Restenosis
- What is being tested?
- Percutaneous Coronary Intervention under OCT and Percutaneous Coronary Intervention under Angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2019to 1 Sep 2020
- 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
- Age 18 years or older
- Patients with angina or evidence of myocardial ischaemia
- Patients with restenotic lesions in a previously DES area of a coronary artery
- Patients suitable to receive any types of percutaneous coronary intervention (including balloon angioplasty and stent implantation)
- The stent diameter of DES-ISR is 2.5mm to 4.0mm
- Target lesion length < 30mm
- Target lesion stenosis ≥ 70% diameter stenosis on visual assessment, or ≥ 50% diameter stenosis and with evidence of myocardial ischaemia ischemic
Who cannot join
- Patients with acute myocardial infarction with 1 week
- Patients with evidence of extensive thrombosis in the target vessel
- Patients with left main coronary artery disease
- Patients with cardiogenic shock, left ventricular ejection fraction < 40%,significant renal dysfunction and severe heart valve disease
- Patients who had cerebral stroke within 6 months before PCI
- Patients with a life expectancy < 1 year
- Patients not able to adhere to follow-up visits
Trial locations and contacts
1 site in 1 country.
Lei Gao contact
About this study
Official title: Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis: A Prospective Registry Trial
This study is a prospective, registry trial aimed to compare the clinical and angiographic outcomes of OCT-guided and angiography-guided PCI in patients with coronary DES-ISR.
- Being tested
- Percutaneous Coronary Intervention under OCT, Percutaneous Coronary Intervention under Angiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary Intervention under OCTProcedure or surgery
After randomization, subjects receive primary PCI under the guiding of OCT
Percutaneous Coronary Intervention under AngiographyProcedure or surgery
After randomization, subjects receive primary PCI under the guiding of angiography
| Study group | Role | What they receive |
|---|---|---|
| OCT-guided PCI | Experimental | Not described Receives: Procedure: Percutaneous Coronary Intervention under OCT |
| Angiography-guided PCI | Sham comparator | Not described Receives: Procedure: Percutaneous Coronary Intervention under Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-segment late loss at 9 months follow-up
Measured: 9 months
Secondary outcomes (6)
Rates of acute success
Measured: 1 month
Rate of 9-month binary restenosis
Measured: 9 months
Number of Participants with target lesion failure (TLF)
Measured: 12 months
Rate of major adverse cardiovascular events
Measured: 12 months
Number of participants with all-cause death
Measured: 12 months
Rate of myocardial infarction
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start1 Mar 2019 (estimated)
- Primary completion1 Mar 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CHD - Coronary Heart DiseaseStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun Dai Chen, Chinese PLA General Hospital
- Investigators
- Yundai Chen, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809754
- Sponsor's protocol ID
- Z171100001017158
- Status last verified
- Jan 2019
- First submitted
- 15 Jan 2019
- Last updated
- 23 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Han Y, Yuan X, Wang W, Wang N, Zhang Y, Jing J, Chen Y, Gao L. Clinical Significance of Optical Coherence Tomography-Guided Percutaneous Coronary Intervention for In-Stent Restenosis Within Drug-Eluting Stents: Impact on Patient Outcomes. J Am Heart Assoc. 2024 Nov 5;13(21):e033954. doi: 10.1161/JAHA.123.033954. Epub 2024 Nov 4.
PubMed 39494577
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography Guided Percutaneous Coronary Intervention for Drug-eluting In-stent Restenosis: A Prospective Registry Trial
- ClinicalTrials.gov ID
- NCT03809754
- Acronym / sponsor ID
- Z171100001017158
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (estimated)
- Primary completion
- 1 Mar 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 18 Jan 2019 (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, registry trial aimed to compare the clinical and angiographic outcomes of OCT-guided and angiography-guided PCI in patients with coronary DES-ISR.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCT-guided PCI | Experimental | Procedure: Percutaneous Coronary Intervention under OCT |
| Angiography-guided PCI | Sham comparator | Procedure: Percutaneous Coronary Intervention under Angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- Patients with angina or evidence of myocardial ischaemia
- Patients with restenotic lesions in a previously DES area of a coronary artery
- Patients suitable to receive any types of percutaneous coronary intervention (including balloon angioplasty and stent implantation)
- The stent diameter of DES-ISR is 2.5mm to 4.0mm
Key exclusion criteria (7 listed)
- Patients with acute myocardial infarction with 1 week
- Patients with evidence of extensive thrombosis in the target vessel
- Patients with left main coronary artery disease
- Patients with cardiogenic shock, left ventricular ejection fraction < 40%,significant renal dysfunction and severe heart valve disease
- Patients who had cerebral stroke within 6 months before PCI
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 |
|---|---|---|
| Percutaneous Coronary Intervention under OCTAfter randomization, subjects receive primary PCI under the guiding of OCT | Procedure or surgery | OCT-guided PCI |
| Percutaneous Coronary Intervention under AngiographyAfter randomization, subjects receive primary PCI under the guiding of angiography | Procedure or surgery | Angiography-guided PCI |
Primary outcome
In-segment late loss at 9 months follow-up
Time frame: 9 months
6 secondary outcomes
Rates of acute success
Time frame: 1 month
Rate of 9-month binary restenosis
Time frame: 9 months
Number of Participants with target lesion failure (TLF)
Time frame: 12 months
Rate of major adverse cardiovascular events
Time frame: 12 months
Number of participants with all-cause death
Time frame: 12 months
Rate of myocardial infarction
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Derived from this study: PubMed 39494577Han Y, Yuan X, Wang W, Wang N, Zhang Y, Jing J, Chen Y, Gao L. Clinical Significance of Optical Coherence Tomography-Guided Percutaneous Coronary Intervention for In-Stent Restenosis Within Drug-Eluting Stents: Impact on Patient Outcomes. J Am Heart Assoc. 2024 Nov 5;13(21):e033954. doi: 10.1161/JAHA.123.033954. Epub 2024 Nov 4.
- Individual participant dataSharing planned: Undecided
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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.
Lei Gao contact
Yundai Chen principal investigator
Chinese PLA General 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 Percutaneous Coronary Intervention under OCT and Percutaneous Coronary Intervention under Angiography in people with CHD - Coronary Heart Disease and Percutaneous Coronary Intervention, run by Chinese PLA General Hospital 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 7 inclusion and 7 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 23 Jan 2019. 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. Some participants in this study may receive a placebo. 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 Yundai Chen (+8601055499135, yundaichen@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-segment late loss at 9 months follow-up (time frame: 9 months). 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 NCT03809754, which also lists 1 linked publication.
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 23 Jan 2019.