DCB Treatment in CTO Guided by IVUS

NCT ID: NCT06050096

Last Updated: 2023-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2025-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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DCB group

CTO patients treated by DCB

PCI

Intervention Type PROCEDURE

CTO patients treated by DCB

Interventions

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PCI

CTO patients treated by DCB

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Patients with severe contrast allergy who cannot tolerate coronary angiography;
2. Patients known allergy to drug balloon coating;
3. Patients who is pregnant or breastfeeding;
4. Bleeding or other diseases, such as digestive tract ulcers, blood system diseases, etc., limit the use of platelet aggregation inhibitors and anticoagulation therapy;
5. Patients with cardiac shock;
6. Patients with a life expectancy of less than 1 year;
7. Other situations deemed unsuitable for inclusion by the researcher.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuzhou Central Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chenpengsheng

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Pengsheng Chen, MD

Role: primary

+86 18112000296

References

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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.

Reference Type RESULT
PMID: 30165437 (View on PubMed)

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.

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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.

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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.

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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.

Reference Type RESULT
PMID: 28582023 (View on PubMed)

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.

Reference Type RESULT
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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.

Reference Type RESULT
PMID: 28114677 (View on PubMed)

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.

Reference Type RESULT
PMID: 31686536 (View on PubMed)

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.

Reference Type RESULT
PMID: 32466881 (View on PubMed)

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.

Reference Type RESULT
PMID: 27741486 (View on PubMed)

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Reference Type RESULT
PMID: 32473887 (View on PubMed)

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.

Reference Type RESULT
PMID: 23040575 (View on PubMed)

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.

Reference Type RESULT
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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.

Reference Type RESULT
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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.

Reference Type RESULT
PMID: 29726047 (View on PubMed)

Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id

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