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Clinical study of optical coherence tomography in the interventional treatment of coronary drug-eluting stent restenosis

Clinical study of optical coherence tomography in the interventional treatment of coronary drug-eluting stent restenosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075017
Enrollment
Unknown
Registered
2023-08-23
Start date
2023-04-20
Completion date
Unknown
Last updated
2023-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary drug-eluting in-stent restenosis

Interventions

Experimental group:The "three-step" process of optical coherence tomography guiding interventional therapy for restenosis in drug-eluting stents

Sponsors

Department of Cardiology,First Medical Center of Chinese PLA General Hospital,Beijing 100853,China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. 18 to 80 years old; 2. The diameter of the vascular reference lumen in patients with restenosis in drug-eluting stents was 2.5-4.0mm, and the length of the lesion was no more than 30mm; 3. Diameter stenosis =70% or =50% with evidence of myocardial ischemia.

Exclusion criteria

Exclusion criteria: 1. Acute myocardial infarction within 1 week; 2. Left main or right coronary artery opening lesions; 3. Bifurcation lesions; 4. Intraarterial lesions of bypass transplantation; 5. Severe chronic heart failure or NYHA Level IV; 6. Severe heart valvular disease; 7. Stroke within 6 months before intervention; 8. Severe kidney failure; 9. Recurrent in-stent restenosis.

Design outcomes

Primary

MeasureTime frame
Preoperative minimum lumen diameter;Minimum lumen diameter post-procedure;Angiographic follow-up minimum lumen diameter;Late lumen loss;

Secondary

MeasureTime frame
Lesion length;Reference lumen diameter;Distal reference lumen area;Proximal reference lumen area;Minimum lumen area;Neointimal thickness;Neointimal area;Stent length;Maximum Angle of lipid arc;Fibercap thickness;Plaque properties;Plaque distribution characteristics;The backscatter case;Thin fibrous cap atherosclerotic plaque;Macrophage infiltration;Characteristics and distribution of thrombus;

Countries

China

Contacts

Public ContactLei Gao

Department of Cardiology,First Medical Center of Chinese PLA General Hospital,Beijing 100853,China

nkgaolei2010@126.com+86 136 6102 2415

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026