DCB Angioplasty for Coronary Lesions: an OCT Analysis

NCT04984135 | Completed DMC

• 1 other identifier: YJ-KY-FB-2021-09
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Stenosis; Drug-coated Balloon

Keywords

Drug-coated balloon; Optical coherence tomography; De-novo coronary lesions; In-stent restenosis

Outcome Measures

Primary Outcomes (1)

• In-segment late lumen loss

  Changes to lumen area assessed with the use of OCT

  6 months

Secondary Outcomes (1)

• Target lesion failure

  6 months

Study Arms (1)

Enrolled patients

Patients fulfilling the study criteria were included.

Procedure: Percutaneous coronary intervention

Interventions

Percutaneous coronary intervention PROCEDURE

All patients were treated with a loading dose of clopidogrel 300 or 600 mg before the procedure followed by maintenance clopidogrel 75 mg daily for 6 months. 100 U/ kg of unfractionated heparin was injected intravenously to maintain an activated clotting time ≥ 250 s during the procedure. For DCB treatment, the patient underwent predilation with an optimal-sized balloon (non-compliant balloon or cutting balloon) based on angiography (balloon-to-vessel ratio of 1.0), with the standard balloon shorter than the intended DCB size. The DCB was sized at 1:1 balloon-to-vessel ratio, delivered rapidly (median of 15 s) and inflated at nominal pressure for 60 s.

Enrolled patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with de-novo or in-stent restenotic coronary lesions were treated with DCB

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital of Dalian Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116011, China

Location

Related Publications (8)

• 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 assessed with optical coherence tomography and mid-term results after percutaneous coronary intervention for in-stent restenosis lesions: a comparison between balloon angioplasty, paclitaxel-coated balloon dilatation, and drug-eluting stent implantation. Eur Heart J Cardiovasc Imaging. 2015 Oct;16(10):1101-11. doi: 10.1093/ehjci/jev031. Epub 2015 Mar 9.

  PMID: 25762559 RESULT

• 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 Stent Restenosis. Circ J. 2018 Oct 25;82(11):2820-2828. doi: 10.1253/circj.CJ-18-0464. Epub 2018 Aug 30.

  PMID: 30158345 RESULT

• 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. 2018 Jan;29(1):39-45. doi: 10.1097/MCA.0000000000000552.

  PMID: 28902718 RESULT

• de la Torre Hernandez JM, Garcia Camarero T, Lozano Ruiz-Poveda F, Urbano-Carrillo CA, Sanchez Perez I, Cano-Garcia M, Saez R, Andres Morist A, Molina E, Pinar E, Torres A, Lezcano EJ, Gutierrez H, Arnold RJ, Zueco J. Angiography and Optical Coherence Tomography Assessment of the Drug-Coated Balloon ESSENTIAL for the Treatment of In-Stent Restenosis. Cardiovasc Revasc Med. 2020 Apr;21(4):508-513. doi: 10.1016/j.carrev.2019.07.021. Epub 2019 Jul 23.

  PMID: 31401071 RESULT

• 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/s00380-019-01346-9. Epub 2019 Jan 30.

  PMID: 30701291 RESULT

• 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/s10554-018-1505-z. Epub 2019 Mar 30.

  PMID: 30929102 RESULT

• Rissanen TT, Uskela S, Eranen J, Mantyla P, Olli A, Romppanen H, Siljander A, Pietila M, Minkkinen MJ, Tervo J, Karkkainen JM; DEBUT trial investigators. Drug-coated balloon for treatment of de-novo coronary artery lesions in patients with high bleeding risk (DEBUT): a single-blind, randomised, non-inferiority trial. Lancet. 2019 Jul 20;394(10194):230-239. doi: 10.1016/S0140-6736(19)31126-2. Epub 2019 Jun 13.

  PMID: 31204115 RESULT

• 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 Interv. 2021 Jul 1;98(1):E35-E42. doi: 10.1002/ccd.29435. Epub 2020 Dec 28.

  PMID: 33369836 RESULT

MeSH Terms

Conditions

Coronary Stenosis

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Lei Guo, MD

  The First Affiliated Hospital of Dalian Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2021
• First Posted: July 30, 2021
• Study Start: December 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 20, 2021
• Last Updated: August 16, 2021

Record last verified: 2021-08

Locations

CN (1)