Northern Hospital
Shenyang, Liaoning, China
Location contact
Yaling Han, Dr
CONTACT
Yaling Han, MD
PRINCIPAL_INVESTIGATOR
Yang Li, MD
SUB_INVESTIGATOR
Yi Li, MD
SUB_INVESTIGATOR
NCT Number: NCT06339021
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Early Phase 1
Shenyang, Liaoning, China
Yaling Han, Dr
CONTACT
Yaling Han, MD
PRINCIPAL_INVESTIGATOR
Yang Li, MD
SUB_INVESTIGATOR
Yi Li, MD
SUB_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
OCT-guided PCI based on MLD MAX algorithm
Conventional angiography-based PCI
Aspirin and clopidogrel 30 days after DES implantation
Aspirin and ticagrelor 30 days 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.
Time frame: During 12-month follow up
Defined as a composite endpoints of all-cause death, myofarction, stroke and clinically indicated revascularization
Time frame: During 12-month follow up
Defined as all BARC type 2-5 bleeding events
Time frame: During 12-month follow up
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.
Contact information is provided by the study sponsor or research team.
Shenyang Northern Hospital
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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