Optical Coherence TomographyEarly Phase 1NCT06339021

OCT or Angiography Guided De-escalation of DAPT

A Early Phase 1 study testing OCT-guided PCI, Conventional angiography-based PCI and DAPT de-escalation in people with Optical Coherence Tomography and Dual Antiplatelet Therapy, run by Shenyang Northern Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Optical Coherence Tomography, Dual Antiplatelet Therapy, Antiplatelet De-escalation
What is being tested?: OCT-guided PCI, Conventional angiography-based PCI and DAPT de-escalation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteChina
Study dates: 1 Apr 2024to 1 Dec 2026
Phase: Early Phase 1
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 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

18 ~ 85 years old adult patients;
Patients diagnosed with STEMI and undergoing PCI.
Patients able and willing to give written informed consent and to comply with the requirements of this study protocol.

Who cannot join

Prior history of intracranial hemorrhage or ischemic stroke during the past 6 months；
Allergy to aspirin or clopidogrel or ticagrelor;
Occurrence of major adverse cardiovascular event (MACE) within 30 days after undergoing PCI;
Platelet count < 50 × 109/L;
Major bleeding during the past 12 months;
Any form of oral, long-term anticoagulation therapy;

Show all 18Show fewer

Pregnancy or lactation;
Suspected aortic dissection;
Coronary CT-negative patients;
Life expectancy <1 year;
Uncontrolled hypertension, systolic blood pressure (SBP) ≥180 mmHg, and/or diastolic blood pressure (DBP) ≥110 mmHg;
Comorbid conditions included the presence of any of the following: cardiogenic shock, chronic congestive heart failure with NYHA classes III or IV, left ventricular ejection fraction (LVEF) < 35% at transthoracic echocardiography, hypotension with SBP < 90mmHg and/or DBP < 60mmHg, severe arrhythmia (including high-degree AV block, sick sinus syndrome, sustained ventricular tachycardia), severe pulmonary insufficiency, pulmonary embolism, hepatic insufficiency due to non-cardiac causes (ALT or AST more than three times the upper limit of the institution's normal reference ranges), cirrhosis, severe renal failure (eGFR < 30ml/min/1.73m2);
Surgery plan within 30 days;
Psychiatric abnormalities or alcohol dependence;
Patients who are participating in other clinical trials;
Unable to tolerate 1 month of DAPT;
Angiographic triple vessel disease coronary disease;
Other situations judged by the investigators not to be suitable for the clinical trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yaling Han contact

86-24-28856123

cardiology@163.com

China1 site

Northern Hospital
Shenyang, Liaoning
Yaling Han, Dr, +86-24-28897313, cardiology@163.com
Yaling Han, MD

Other trials in China

About this study

Official title: Evaluation of Neointimal Coverage After Guiding De-escalation of Antiplatelet Treatment in Patients With ST-elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention by Optical Coherence Tomography or Angiography of STEMI Patients

Optical coherence tomography (OCT) offers a high-resolution intravascular imaging modality to accurately assess vessel and lumen geometry and identify the hallmark of a culprit lesion including plaque disruption and thrombus. In addition, the incorporation of the MLD MAX algorithm into daily practice guides an efficient and easily-memorable workflow for optimized OCT-guided percutaneous coronary intervention (PCI) with drug-eluting stents (DES). Regarding the antithrombotic therapy after revascularization, the 2023 ESC guidelines recommend the P2Y12 receptor inhibitor de-escalation (i.e. switching from ticagrelor to clopidogrel) in ACS patients may be considered as an alternative strategy to the default treatment regimen in order to reduce the risk of bleeding events.

Based on the above conclusions, we designed a single-center, prospective, randomized controlled, exploratory study trial to evaluate whether the utility of OCT for guiding PCI with DES followed by antiplatelet de-escalation therapy could further reduce the stent-induced intimal hyperplasia of STEMI patients after stent implantation.

Conditions: Optical Coherence Tomography, Dual Antiplatelet Therapy, Antiplatelet De-escalation, Neointimal Coverage, ST Elevation Myocardial Infarction
Being tested: OCT-guided PCI, Conventional angiography-based PCI, DAPT de-escalation, default DAPT regimen
Medical subject headings: ST Elevation Myocardial Infarction

What participants receive

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

OCT-guided PCIProcedure or surgery
OCT-guided PCI based on MLD MAX algorithm
Conventional angiography-based PCIProcedure or surgery
Conventional angiography-based PCI
DAPT de-escalationDrug
Aspirin and clopidogrel 30 days after DES implantation
default DAPT regimenDrug
Aspirin and ticagrelor 30 days after DES implantation

Study groups in NCT06339021
Study group	Role	What they receive
OCT-guided PCI and DAPT De-escalation	Experimental	OCT-guided PCI follwed by DAPT de-escalation (aspirin and clopidogrel) 30 days after the DES implantation in STEMI patients Receives: Procedure: OCT-guided PCI; Drug: DAPT de-escalation
OCT-guided PCI and default DAPT regimen	Experimental	OCT-guided PCI follwed by default DAPT regimen (aspirin and ticagrelor) 30 days after the DES implantation in STEMI patients Receives: Procedure: OCT-guided PCI; Drug: default DAPT regimen
Conventional angiography-based PCI and DAPT De-escalation	Experimental	Conventional angiography-based PCI follwed by DAPT de-escalation (aspirin and clopidogrel) 30 days after the DES implantation in STEMI patients Receives: Procedure: Conventional angiography-based PCI; Drug: DAPT de-escalation
Conventional angiography-based PCI and default DAPT regimen	Active comparator	Conventional angiography-based PCI follwed by default DAPT regimen (aspirin and ticagrelor) 30 days after the DES implantation in STEMI patients Receives: Procedure: Conventional angiography-based PCI; Drug: default DAPT regimen

What is being measured

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

Neointimal thickness after DES implantation
Stent and luminal cross-sectional areas (CSAs) were measured. Neointimal CSA was calculated as stent CSA minus lumen CSA. Neointimal thickness was measured as the distance between endoluminal surface of neointima and strut, which was obtained at 12-month follow-up.
Measured: At 12-month follow up after PCI

Secondary outcomes (3)

Major adverse cardiovascular and cerebrovascular events (MACCE)
Defined as a composite endpoints of all-cause death, myofarction, stroke and clinically indicated revascularization
Measured: During 12-month follow up
BARC types 2-5 bleeding
Defined as all BARC type 2-5 bleeding events
Measured: During 12-month follow up
In-stent thrombosis
In-stent thrombosis was defined as new ST elevation with anginal symptoms or an equivalent due to thrombotic occlusion of the stent placed at the culprit lesion confirmed by coronary angiography during the index hospitalization.
Measured: During 12-month follow up

Timeline

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

1 Apr 20241 Dec 2026

First posted1 Apr 2024
Study start1 Apr 2024 (estimated)
Primary completion1 Dec 2026 (estimated)
Study completion1 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
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: Early Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06339021
Sponsor's protocol ID: DAPT-OCT
Status last verified: Mar 2024
First submitted: 24 Mar 2024
Last updated: 1 Apr 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Ali ZA, Karimi Galougahi K, Thomas SV, Abu-Much A, Chau K, Dakroub A, Shlofmitz ES, Jeremias A, West N, Matsumura M, Mintz GS, Maehara A, Shlofmitz RA. Optical Coherence Tomography-Guided Percutaneous Coronary Intervention: Practical Application. Interv Cardiol Clin. 2023 Apr;12(2):215-224. doi: 10.1016/j.iccl.2022.12.003. Epub 2023 Jan 31.
PubMed 36922062
Giugliano RP, Braunwald E. The year in acute coronary syndrome. J Am Coll Cardiol. 2014 Jan 28;63(3):201-14. doi: 10.1016/j.jacc.2013.10.041. Epub 2013 Nov 13. No abstract available.
PubMed 24239661
Bliden KP, Tantry US, Storey RF, Jeong YH, Gesheff M, Wei C, Gurbel PA. The effect of ticagrelor versus clopidogrel on high on-treatment platelet reactivity: combined analysis of the ONSET/OFFSET and RESPOND studies. Am Heart J. 2011 Jul;162(1):160-5. doi: 10.1016/j.ahj.2010.11.025. Epub 2011 Jun 12.
PubMed 21742103
Capodanno D, Alfonso F, Levine GN, Valgimigli M, Angiolillo DJ. ACC/AHA Versus ESC Guidelines on Dual Antiplatelet Therapy: JACC Guideline Comparison. J Am Coll Cardiol. 2018 Dec 11;72(23 Pt A):2915-2931. doi: 10.1016/j.jacc.2018.09.057.
PubMed 30522654
Cuisset T, Deharo P, Quilici J, Johnson TW, Deffarges S, Bassez C, Bonnet G, Fourcade L, Mouret JP, Lambert M, Verdier V, Morange PE, Alessi MC, Bonnet JL. Benefit of switching dual antiplatelet therapy after acute coronary syndrome: the TOPIC (timing of platelet inhibition after acute coronary syndrome) randomized study. Eur Heart J. 2017 Nov 1;38(41):3070-3078. doi: 10.1093/eurheartj/ehx175.
PubMed 28510646
Sibbing D, Aradi D, Jacobshagen C, Gross L, Trenk D, Geisler T, Orban M, Hadamitzky M, Merkely B, Kiss RG, Komocsi A, Dezsi CA, Holdt L, Felix SB, Parma R, Klopotowski M, Schwinger RHG, Rieber J, Huber K, Neumann FJ, Koltowski L, Mehilli J, Huczek Z, Massberg S; TROPICAL-ACS Investigators. Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS): a randomised, open-label, multicentre trial. Lancet. 2017 Oct 14;390(10104):1747-1757. doi: 10.1016/S0140-6736(17)32155-4. Epub 2017 Aug 28.
PubMed 28855078
Bonello L, Laine M, Kipson N, Mancini J, Helal O, Fromonot J, Gariboldi V, Condo J, Thuny F, Frere C, Camoin-Jau L, Paganelli F, Dignat-George F, Guieu R. Ticagrelor increases adenosine plasma concentration in patients with an acute coronary syndrome. J Am Coll Cardiol. 2014 Mar 11;63(9):872-7. doi: 10.1016/j.jacc.2013.09.067. Epub 2013 Nov 27.
PubMed 24291273
Kim CJ, Park MW, Kim MC, Choo EH, Hwang BH, Lee KY, Choi YS, Kim HY, Yoo KD, Jeon DS, Shin ES, Jeong YH, Seung KB, Jeong MH, Yim HW, Ahn Y, Chang K; TALOS-AMI investigators. Unguided de-escalation from ticagrelor to clopidogrel in stabilised patients with acute myocardial infarction undergoing percutaneous coronary intervention (TALOS-AMI): an investigator-initiated, open-label, multicentre, non-inferiority, randomised trial. Lancet. 2021 Oct 9;398(10308):1305-1316. doi: 10.1016/S0140-6736(21)01445-8.
PubMed 34627490
Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.
PubMed 37622654

Interested in taking part?

Yaling Han

86-24-28856123

cardiology@163.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Optical Coherence Tomography trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Neointimal Coverage After Guiding De-escalation of Antiplatelet Treatment in Patients With ST-elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention by Optical Coherence Tomography or Angiography of STEMI Patients
ClinicalTrials.gov ID: NCT06339021
Acronym / sponsor ID: DAPT-OCT
Conditions: Optical Coherence Tomography, Dual Antiplatelet Therapy, Antiplatelet De-escalation, Neointimal Coverage, ST Elevation Myocardial Infarction
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 80 participants (estimated)
Lead sponsor: Shenyang Northern HospitalUniversity, hospital or other
Study start: 1 Apr 2024 (estimated)
Primary completion: 1 Dec 2026 (estimated)
Study completion: 1 Dec 2026 (estimated)
First posted: 1 Apr 2024 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
OCT-guided PCI and DAPT De-escalation	Experimental	Procedure: OCT-guided PCI, Drug: DAPT de-escalationOCT-guided PCI follwed by DAPT de-escalation (aspirin and clopidogrel) 30 days after the DES implantation in STEMI patients
OCT-guided PCI and default DAPT regimen	Experimental	Procedure: OCT-guided PCI, Drug: default DAPT regimenOCT-guided PCI follwed by default DAPT regimen (aspirin and ticagrelor) 30 days after the DES implantation in STEMI patients
Conventional angiography-based PCI and DAPT De-escalation	Experimental	Procedure: Conventional angiography-based PCI, Drug: DAPT de-escalationConventional angiography-based PCI follwed by DAPT de-escalation (aspirin and clopidogrel) 30 days after the DES implantation in STEMI patients
Conventional angiography-based PCI and default DAPT regimen	Active comparator	Procedure: Conventional angiography-based PCI, Drug: default DAPT regimenConventional angiography-based PCI follwed by default DAPT regimen (aspirin and ticagrelor) 30 days after the DES implantation in STEMI patients

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

18 ~ 85 years old adult patients;
Patients diagnosed with STEMI and undergoing PCI.
Patients able and willing to give written informed consent and to comply with the requirements of this study protocol.

Key exclusion criteria (18 listed)

Prior history of intracranial hemorrhage or ischemic stroke during the past 6 months；
Allergy to aspirin or clopidogrel or ticagrelor;
Occurrence of major adverse cardiovascular event (MACE) within 30 days after undergoing PCI;
Platelet count < 50 × 109/L;
Major bleeding during the past 12 months;

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-guided PCIOCT-guided PCI based on MLD MAX algorithm	Procedure or surgery	OCT-guided PCI and DAPT De-escalation, OCT-guided PCI and default DAPT regimen
Conventional angiography-based PCIConventional angiography-based PCI	Procedure or surgery	Conventional angiography-based PCI and DAPT De-escalation, Conventional angiography-based PCI and default DAPT regimen
DAPT de-escalationAspirin and clopidogrel 30 days after DES implantation	Drug	Conventional angiography-based PCI and DAPT De-escalation, OCT-guided PCI and DAPT De-escalation
default DAPT regimenAspirin and ticagrelor 30 days after DES implantation	Drug	Conventional angiography-based PCI and default DAPT regimen, OCT-guided PCI and default DAPT regimen

Primary outcome

Neointimal thickness after DES implantation
Time frame: At 12-month follow up after PCI
Stent and luminal cross-sectional areas (CSAs) were measured. Neointimal CSA was calculated as stent CSA minus lumen CSA. Neointimal thickness was measured as the distance between endoluminal surface of neointima and strut, which was obtained at 12-month follow-up.

3 secondary outcomes

Major adverse cardiovascular and cerebrovascular events (MACCE)
Time frame: During 12-month follow up
BARC types 2-5 bleeding
Time frame: During 12-month follow up
In-stent thrombosis
Time frame: During 12-month follow up

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 1 Apr 2024.
Background: PubMed 36922062Ali ZA, Karimi Galougahi K, Thomas SV, Abu-Much A, Chau K, Dakroub A, Shlofmitz ES, Jeremias A, West N, Matsumura M, Mintz GS, Maehara A, Shlofmitz RA. Optical Coherence Tomography-Guided Percutaneous Coronary Intervention: Practical Application. Interv Cardiol Clin. 2023 Apr;12(2):215-224. doi: 10.1016/j.iccl.2022.12.003. Epub 2023 Jan 31.
Background: PubMed 24239661Giugliano RP, Braunwald E. The year in acute coronary syndrome. J Am Coll Cardiol. 2014 Jan 28;63(3):201-14. doi: 10.1016/j.jacc.2013.10.041. Epub 2013 Nov 13. No abstract available.
Background: PubMed 21742103Bliden KP, Tantry US, Storey RF, Jeong YH, Gesheff M, Wei C, Gurbel PA. The effect of ticagrelor versus clopidogrel on high on-treatment platelet reactivity: combined analysis of the ONSET/OFFSET and RESPOND studies. Am Heart J. 2011 Jul;162(1):160-5. doi: 10.1016/j.ahj.2010.11.025. Epub 2011 Jun 12.
Background: PubMed 30522654Capodanno D, Alfonso F, Levine GN, Valgimigli M, Angiolillo DJ. ACC/AHA Versus ESC Guidelines on Dual Antiplatelet Therapy: JACC Guideline Comparison. J Am Coll Cardiol. 2018 Dec 11;72(23 Pt A):2915-2931. doi: 10.1016/j.jacc.2018.09.057.
Background: PubMed 28510646Cuisset T, Deharo P, Quilici J, Johnson TW, Deffarges S, Bassez C, Bonnet G, Fourcade L, Mouret JP, Lambert M, Verdier V, Morange PE, Alessi MC, Bonnet JL. Benefit of switching dual antiplatelet therapy after acute coronary syndrome: the TOPIC (timing of platelet inhibition after acute coronary syndrome) randomized study. Eur Heart J. 2017 Nov 1;38(41):3070-3078. doi: 10.1093/eurheartj/ehx175.
Background: PubMed 28855078Sibbing D, Aradi D, Jacobshagen C, Gross L, Trenk D, Geisler T, Orban M, Hadamitzky M, Merkely B, Kiss RG, Komocsi A, Dezsi CA, Holdt L, Felix SB, Parma R, Klopotowski M, Schwinger RHG, Rieber J, Huber K, Neumann FJ, Koltowski L, Mehilli J, Huczek Z, Massberg S; TROPICAL-ACS Investigators. Guided de-escalation of antiplatelet treatment in patients with acute coronary syndrome undergoing percutaneous coronary intervention (TROPICAL-ACS): a randomised, open-label, multicentre trial. Lancet. 2017 Oct 14;390(10104):1747-1757. doi: 10.1016/S0140-6736(17)32155-4. Epub 2017 Aug 28.
Background: PubMed 24291273Bonello L, Laine M, Kipson N, Mancini J, Helal O, Fromonot J, Gariboldi V, Condo J, Thuny F, Frere C, Camoin-Jau L, Paganelli F, Dignat-George F, Guieu R. Ticagrelor increases adenosine plasma concentration in patients with an acute coronary syndrome. J Am Coll Cardiol. 2014 Mar 11;63(9):872-7. doi: 10.1016/j.jacc.2013.09.067. Epub 2013 Nov 27.
Background: PubMed 34627490Kim CJ, Park MW, Kim MC, Choo EH, Hwang BH, Lee KY, Choi YS, Kim HY, Yoo KD, Jeon DS, Shin ES, Jeong YH, Seung KB, Jeong MH, Yim HW, Ahn Y, Chang K; TALOS-AMI investigators. Unguided de-escalation from ticagrelor to clopidogrel in stabilised patients with acute myocardial infarction undergoing percutaneous coronary intervention (TALOS-AMI): an investigator-initiated, open-label, multicentre, non-inferiority, randomised trial. Lancet. 2021 Oct 9;398(10308):1305-1316. doi: 10.1016/S0140-6736(21)01445-8.
Background: PubMed 37622654Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023 Oct 12;44(38):3720-3826. doi: 10.1093/eurheartj/ehad191. No abstract available.
Individual participant dataSharing planned: No

Related trials for Optical Coherence Tomography

Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
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RecruitingObservational study
Validation of Interleukins and Other Cytokines Together With OCT Imaging for Rapid Infectious Keratitis Assessment
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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.

Yaling Han contact

86-24-28856123

cardiology@163.com

Yaling Han principal investigator

Shenyang Northern Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 18 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: opening soon, as of the sponsor's last update on 1 Apr 2024. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact Yaling Han (86-24-28856123, cardiology@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neointimal thickness after DES implantation (time frame: At 12-month follow up after PCI). 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 NCT06339021, which also lists 9 linked publications.

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 1 Apr 2024.