DCB Treatment in CTO Guided by IVUS

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06050096
• Other study ID #: 001
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: October 1, 2025

Study information

• Verified date: September 2023
• Source: Xuzhou Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2025
• Est. primary completion date: August 31, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• PCI
CTO patients treated by DCB

Locations

Country	Name	City	State
China	Xuzhou Central Hospital	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xuzhou Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (15)

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. — View Citation

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. — View Citation

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 Occlu — View Citation

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. D — View Citation

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. — View Citation

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 Internatio — View Citation

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.20 — View Citation

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. — View Citation

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 stud — View Citation

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 Coro — View Citation

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 — View Citation

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 Chro — View Citation

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. d — View Citation

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 regist — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of major adverse cardiovascular events (MACE) in 12 month	cardiovascular death, nonfatal myocardial infarction, and target vessel revascularization	12 month
Secondary	Rate of cardiovascular death in 12 month		12 month
Secondary	Rate of nonfatal myocardial infarction in 12 month		12 month
Secondary	Rate of target vessel revascularization in 12 month		12 month
Secondary	Rate of procedure success rate after PCI		1 day
Secondary	Rate of technical success after PCI		1 day
Secondary	Rate of minor bleeding events		12 month
Secondary	Rate of major bleeding events		12 month