Coronary Stenosis Clinical Trial
Official title:
Drug-coated Balloon Angioplasty for De-novo or in-Stent Restenotic Coronary Lesions: an Optical Coherence Tomography Analysis
In this study, the investigators preformed OCT before and after DCB treatment, as well as at 6 months of follow-up, to assess the tissue characterization. The aim of this study was to investigate the relationship between quantitative and qualitative OCT findings, angiographic and clinical outcomes after PCB for coronary lesions.
Status | Completed |
Enrollment | 70 |
Est. completion date | July 20, 2021 |
Est. primary completion date | July 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Coronary angiography shows that at least one coronary artery has a diameter stenosis >70% (left main stem diameter stenosis>50%) - Stable or unstable angina - Availability for follow-up for up to 12 months Exclusion Criteria: - Acute myocardial infarction within 48 hours - Severe calcified lesions - Unable to tolerate dual antiplatelet treatment (DAPT) - Severe abnormal hematopoietic system, such as platelet count of < 100×109/L or > 700×109/L and white blood cell count of < 3×109/L - Active bleeding or bleeding tendency - Severe coexisting conditions, such as severe renal insufficiency (GFR < 60 ml/min•1.73m2), severe hepatic dysfunction [elevated ALT (glutamicpyruvic transaminase) or AST (glutamic-oxal acetic transaminase) level by more than three-fold of the normal limitation], acute or chronic heart failure (NYHA III-IV), acute infectious diseases, immune disorders, malignancy, etc. - Life expectancy < 12 months - Pregnancy or planning pregnancy - Drug allergies or contraindications to aspirin, clopidogrel, ticagrelor, statins, contract, anticoagulant, stent, etc. - Participation or planning to participate in another clinical trial during the same period - Refusal to comply with the study protocol |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Dalian Medical University | Dalian | Liaoning |
Lead Sponsor | Collaborator |
---|---|
The First Affiliated Hospital of Dalian Medical University |
China,
de la Torre Hernández JM, Garcia Camarero T, Lozano Ruiz-Poveda F, Urbano-Carrillo CA, Sánchez Pérez I, Cano-García M, Saez R, Andrés Morist A, Molina E, Pinar E, Torres A, Lezcano EJ, Gutierrez H, Arnold RJ, Zueco J. Angiography and Optical Coherence Tom — View Citation
Fukushima T, Ashikaga T, Yoshikawa S, Hatano Y, Ueshima D, Yamamoto T, Yasuhiro M, Isobe M. Effect of drug-coated balloon on stent restenosis, neointimal proliferation, and coronary dissection: an optical coherence tomography analysis. Coron Artery Dis. 2 — View Citation
Her AY, Shin ES, Chung JH, Kim YH, Garg S, Lee JM, Doh JH, Nam CW, Koo BK. Plaque modification and stabilization after paclitaxel-coated balloon treatment for de novo coronary lesions. Heart Vessels. 2019 Jul;34(7):1113-1121. doi: 10.1007/s00380-019-01346 — View Citation
Liu Y, Zhang YJ, Deng LX, Yin ZY, Hu T, Wang Q, Li Y, Li JY, Guo WY, Mou FJ, Tao L. 12-Month clinical results of drug-coated balloons for de novo coronary lesion in vessels exceeding 3.0 mm. Int J Cardiovasc Imaging. 2019 Apr;35(4):579-586. doi: 10.1007/s — View Citation
Miura K, Tada T, Habara S, Kuwayama A, Shimada T, Ohya M, Murai R, Amano H, Kubo S, Otsuru S, Tanaka H, Fuku Y, Goto T, Kadota K. Optical Coherence Tomography Predictors for Recurrent Restenosis After Paclitaxel-Coated Balloon Angioplasty for Drug-Eluting — View Citation
Rissanen TT, Uskela S, Eränen J, Mäntylä P, Olli A, Romppanen H, Siljander A, Pietilä M, Minkkinen MJ, Tervo J, Kärkkäinen JM; DEBUT trial investigators. Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding r — View Citation
Sogabe K, Koide M, Fukui K, Kato Y, Kitajima H, Akabame S, Zen K, Nakamura T, Matoba S. Optical coherence tomography analysis of late lumen enlargement after paclitaxel-coated balloon angioplasty for de-novo coronary artery disease. Catheter Cardiovasc In — View Citation
Tada T, Kadota K, Hosogi S, Miyake K, Ohya M, Amano H, Izawa Y, Kanazawa T, Kubo S, Ichinohe T, Hyoudou Y, Hayakawa Y, Sabbah MM, Otsuru S, Hasegawa D, Habara S, Tanaka H, Fuku Y, Katoh H, Goto T, Mitsudo K. Association between tissue characteristics asse — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | In-segment late lumen loss | Changes to lumen area assessed with the use of OCT | 6 months | |
Secondary | Target lesion failure | The secondary endpoint was the incidence of target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization (TLR) at 6 months. | 6 months |
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