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Coronary Artery DiseaseNCT06050096

DCB Treatment in CTO Guided by IVUS

An observational study of Coronary Artery Disease, run by Xuzhou Central Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
PCI
Type of treatment
Surgery or procedure
How many people
100 participants
Where
1 siteChina
Study dates
1 Sep 2023to 1 Oct 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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;
  • Other situations deemed unsuitable for inclusion by the researcher.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Xuzhou Central Hospital

    Xuzhou, Jiangsu, 221000

    Pengsheng Chen, MD, +86 18112000296, chenpengsheng@njmu.edu.cn

    Pengsheng Chen, MD

    Recruiting

Other trials in China

About this study

Official title: Drug-coated Balloons Treatment in Chronic Total Occlusion Coronary Artery Disease Guided by Intravascular Ultrasound

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.

Being tested
PCI
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PCIProcedure or surgery

    CTO patients treated by DCB

Study groups in NCT06050096
Study groupRoleWhat they receive
DCB groupCTO patients treated by DCB
Receives: Procedure: PCI

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    cardiovascular death, nonfatal myocardial infarction, and target vessel revascularization

    Measured: 12 month

Secondary outcomes (7)

  1. Rate of cardiovascular death in 12 month

    Measured: 12 month

  2. Rate of nonfatal myocardial infarction in 12 month

    Measured: 12 month

  3. Rate of target vessel revascularization in 12 month

    Measured: 12 month

  4. Rate of procedure success rate after PCI

    Measured: 1 day

  5. Rate of technical success after PCI

    Measured: 1 day

  6. Rate of minor bleeding events

    Measured: 12 month

  7. Rate of major bleeding events

    Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2023
  2. Study start1 Sep 2023
  3. Primary completion31 Aug 2025 (estimated)
  4. Study completion1 Oct 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06050096
Sponsor's protocol ID
001
Status last verified
Sep 2023
First submitted
8 Sep 2023
Last updated
22 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30165437

  • 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.

    PubMed 29550088

  • 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.

    PubMed 19737682

  • 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.

    PubMed 19294443

  • 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.

    PubMed 28582023

  • 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.

    PubMed 32057373

  • 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.

    PubMed 28114677

  • 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.

    PubMed 31686536

  • 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.

    PubMed 32466881

  • 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.

    PubMed 27741486

  • 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.

    PubMed 32473887

  • 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.

    PubMed 23040575

  • 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.

    PubMed 35498010

  • 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.

    PubMed 32583405

  • 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.

    PubMed 29726047

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by Xuzhou Central Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of major adverse cardiovascular events (MACE) in 12 month (time frame: 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06050096, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2023.

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