NCT06050096

Brief Summary

The percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) coronary artery disease is difficult, the success rate is low, and the incidence of re-occlusion and restenosis is high. With the wide application of imaging technology represented by intravascular ultrasound (IVUS), the success rate of CTO PCI has been significantly improved. Drug-coated balloons (DCB), as a treatment without metal implantation, has lower lumen loss and no significant increase in the rate of revascularization. Through IVUS measurement of vascular lumen after CTO opening, appropriate instruments can be selected for adequate dilation, and appropriate treatment methods can be selected according to different lumen structures. Therefore, the purpose of this study was to evaluate the clinical effect of IVUS-guided DCB therapy on CTO lesions.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

September 8, 2023

Last Update Submit

September 16, 2023

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Rate of major adverse cardiovascular events (MACE) in 12 month

    cardiovascular death, nonfatal myocardial infarction, and target vessel revascularization

    12 month

Secondary Outcomes (7)

  • Rate of cardiovascular death in 12 month

    12 month

  • Rate of nonfatal myocardial infarction in 12 month

    12 month

  • Rate of target vessel revascularization in 12 month

    12 month

  • Rate of procedure success rate after PCI

    1 day

  • Rate of technical success after PCI

    1 day

  • +2 more secondary outcomes

Study Arms (1)

DCB group

CTO patients treated by DCB

Procedure: PCI

Interventions

PCIPROCEDURE

CTO patients treated by DCB

DCB group

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Among CTO lesions previously treated with DCB, the incidence of restenosis was 11.8%, with a sample size of 90-110. This is an observational study on the treatment of CTO, and all patients with CTO lesions were nonselectively enrolled. Continuous enrollment of CTO patients from September 2023 to August 2024 (an estimated 100 cases) was designed to observe the clinical effect of IVUS-directed DCB therapy on CTO lesions.

You may qualify if:

  • Over the age of 18, male or female;
  • Patients who meet the diagnostic criteria for coronary heart disease, have clinical symptoms and seek interventional treatment;
  • Coronary angiography confirmed that the blood vessels met the diagnostic criteria of CTO;
  • Sign informed consent and be willing to undergo follow-up for at least 12 months.

You may not qualify if:

  • Patients with severe contrast allergy who cannot tolerate coronary angiography;
  • Patients known allergy to drug balloon coating;
  • Patients who is pregnant or breastfeeding;
  • Bleeding or other diseases, such as digestive tract ulcers, blood system diseases, etc., limit the use of platelet aggregation inhibitors and anticoagulation therapy;
  • Patients with cardiac shock;
  • Patients with a life expectancy of less than 1 year;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xuzhou Central Hospital

Xuzhou, Jiangsu, 221000, China

RECRUITING

Related Publications (15)

  • Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.

    PMID: 30165437RESULT

  • Tajti P, Burke MN, Karmpaliotis D, Alaswad K, Werner GS, Azzalini L, Carlino M, Patel M, Mashayekhi K, Egred M, Krestyaninov O, Khelimskii D, Nicholson WJ, Ungi I, Galassi AR, Banerjee S, Brilakis ES. Update in the Percutaneous Management of Coronary Chronic Total Occlusions. JACC Cardiovasc Interv. 2018 Apr 9;11(7):615-625. doi: 10.1016/j.jcin.2017.10.052. Epub 2018 Mar 14.

    PMID: 29550088RESULT

  • Di Mario C, Werner GS, Sianos G, Galassi AR, Buttner J, Dudek D, Chevalier B, Lefevre T, Schofer J, Koolen J, Sievert H, Reimers B, Fajadet J, Colombo A, Gershlick A, Serruys PW, Reifart N. European perspective in the recanalisation of Chronic Total Occlusions (CTO): consensus document from the EuroCTO Club. EuroIntervention. 2007 May;3(1):30-43. No abstract available.

    PMID: 19737682RESULT

  • Werner GS, Gitt AK, Zeymer U, Juenger C, Towae F, Wienbergen H, Senges J. Chronic total coronary occlusions in patients with stable angina pectoris: impact on therapy and outcome in present day clinical practice. Clin Res Cardiol. 2009 Jul;98(7):435-41. doi: 10.1007/s00392-009-0013-5. Epub 2009 Mar 18.

    PMID: 19294443RESULT

  • Brilakis ES, Karmpaliotis D, Patel V, Banerjee S. Complications of Chronic Total Occlusion Angioplasty. Interv Cardiol Clin. 2012 Jul;1(3):373-389. doi: 10.1016/j.iccl.2012.04.006. Epub 2012 May 31.

    PMID: 28582023RESULT

  • Madhavan MV, Kirtane AJ, Redfors B, Genereux P, Ben-Yehuda O, Palmerini T, Benedetto U, Biondi-Zoccai G, Smits PC, von Birgelen C, Mehran R, McAndrew T, Serruys PW, Leon MB, Pocock SJ, Stone GW. Stent-Related Adverse Events >1 Year After Percutaneous Coronary Intervention. J Am Coll Cardiol. 2020 Feb 18;75(6):590-604. doi: 10.1016/j.jacc.2019.11.058.

    PMID: 32057373RESULT

  • Kereiakes DJ. The TWENTE Trial in Perspective: Stents and Stent Trials in Evolution. JAMA Cardiol. 2017 Mar 1;2(3):235-237. doi: 10.1001/jamacardio.2016.5208. No abstract available.

    PMID: 28114677RESULT

  • Buccheri D, Lombardo RM, Cortese B. Drug-coated balloons for coronary artery disease: current concepts and controversies. Future Cardiol. 2019 Nov;15(6):437-454. doi: 10.2217/fca-2019-0009. Epub 2019 Nov 5.

    PMID: 31686536RESULT

  • Giacoppo D, Alfonso F, Xu B, Claessen BEPM, Adriaenssens T, Jensen C, Perez-Vizcayno MJ, Kang DY, Degenhardt R, Pleva L, Baan J, Cuesta J, Park DW, Kukla P, Jimenez-Quevedo P, Unverdorben M, Gao R, Naber CK, Park SJ, Henriques JPS, Kastrati A, Byrne RA. Drug-Coated Balloon Angioplasty Versus Drug-Eluting Stent Implantation in Patients With Coronary Stent Restenosis. J Am Coll Cardiol. 2020 Jun 2;75(21):2664-2678. doi: 10.1016/j.jacc.2020.04.006.

    PMID: 32466881RESULT

  • Koln PJ, Scheller B, Liew HB, Rissanen TT, Ahmad WA, Weser R, Hauschild T, Nuruddin AA, Clever YP, Ho HH, Kleber FX. Treatment of chronic total occlusions in native coronary arteries by drug-coated balloons without stenting - A feasibility and safety study. Int J Cardiol. 2016 Dec 15;225:262-267. doi: 10.1016/j.ijcard.2016.09.105. Epub 2016 Sep 27.

    PMID: 27741486RESULT

  • Jeger RV, Eccleshall S, Wan Ahmad WA, Ge J, Poerner TC, Shin ES, Alfonso F, Latib A, Ong PJ, Rissanen TT, Saucedo J, Scheller B, Kleber FX; International DCB Consensus Group. Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1391-1402. doi: 10.1016/j.jcin.2020.02.043. Epub 2020 May 27.

    PMID: 32473887RESULT

  • Wohrle J, Zadura M, Mobius-Winkler S, Leschke M, Opitz C, Ahmed W, Barragan P, Simon JP, Cassel G, Scheller B. SeQuentPlease World Wide Registry: clinical results of SeQuent please paclitaxel-coated balloon angioplasty in a large-scale, prospective registry study. J Am Coll Cardiol. 2012 Oct 30;60(18):1733-8. doi: 10.1016/j.jacc.2012.07.040. Epub 2012 Oct 3.

    PMID: 23040575RESULT

  • Jun EJ, Shin ES, Teoh EV, Bhak Y, Yuan SL, Chu CM, Garg S, Liew HB. Clinical Outcomes of Drug-Coated Balloon Treatment After Successful Revascularization of de novo Chronic Total Occlusions. Front Cardiovasc Med. 2022 Apr 13;9:821380. doi: 10.3389/fcvm.2022.821380. eCollection 2022.

    PMID: 35498010RESULT

  • Yuan SL, Kim MH, Garg S, Shin ES. A case of drug-coated balloon treatment for two total occluded lesions in a patient with acute coronary syndrome. Cardiol J. 2020;27(3):320-321. doi: 10.5603/CJ.2020.0083. No abstract available.

    PMID: 32583405RESULT

  • Huang WC, Teng HI, Hsueh CH, Lin SJ, Chan WL, Lu TM. Intravascular ultrasound guided wiring re-entry technique for complex chronic total occlusions. J Interv Cardiol. 2018 Oct;31(5):572-579. doi: 10.1111/joic.12518. Epub 2018 May 3.

    PMID: 29726047RESULT

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 22, 2023

Study Start

September 1, 2023

Primary Completion

August 31, 2025

Study Completion

October 1, 2025

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)