Angioplasty With Paclitaxel-coated Balloon Only Strategy for Coronary de Novo Lesions

Coronary Disease Clinical Trial

— DCB-denovo  

Official title:

Long Term Clinical Outcomes of Angioplasty With Paclitaxel-coated Balloon Only Strategy for Coronary de Novo Lesions: a Single Center Registry Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04022200
• Other study ID #: BJH DCB for de novo
• Status: Recruiting
• Start date: August 1, 2019
• Est. completion date: July 31, 2023

Study information

• Verified date: March 2022
• Source: Beijing Hospital
• Contact: Xue Yu, MD
• Phone: 00861085132266
• Email: yuxuemd[@]aliyun.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Drug-coating balloon (DCB) is a new interventional device for treatment of obstructive coronary artery disease (CAD). There is limited data on the long term efficacy and safety of DCB-only strategy for coronary de novo lesions in Asian patients. We therefore carry out this registry study to evaluated the clinical outcomes of paclitaxel DCB in Chinese patients in a real world medical practice.

Description:

DCB has emerged as a new interventional option to treat obstructive CAD. Characterized by non-stent-based local drug delivery system, DCB has several advantages over drug-eluting stent(DES).Paclitaxel DCB inhibits excessive neointimal hyperplasia of a diseased lesions without leaving a permanent metallic frame, therefore reducing the risk of coronary thrombosis and eliminating adverse events associated with stent fracture, allergic reactions to metal struts or polymer. Since only 1 to 3 months duration of dual anti-platelet therapy(DAPT) is required after DCB intervention, the bleeding risk associated with prolonged DAPT is reduced. DCB angioplasty was proved safe in an all-comers, prospective, multicenter registry and confirmed not inferior to DES when treating small coronary lesions in a randomized clinical trial(BASKET SMALL-2). DCB has been used in"off-label"indications in the"real world" for de novo lesions, especially in vessels with diameter more than 2.75mm, and there is limited data on its long term clinical efficacy and safety in Asian patients in contemporary clinical registries. We therefore sought to evaluate the long term clinical outcome of DCB in treatment of coronary de novo lesions in Chinese patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient-related criteria:

• Patients with stable angina, unstable angina, myocardial infarction or evidence of asymptomatic myocardial ischemia and consent to receive coronary intervention therapy;

• Consent to receive clinical follow up at 30 days, 3, 6, 12 and 24 months.

• Consent to receive one angiographic follow up at 24 months after procedure.

2. Lesion-related criteria:

• Target coronary lesions without previous intervention therapy;

• The lesions was intervened only with DCB;

• The distance between other lesions requiring intervention therapy and the target lesion must >10mm.

Exclusion Criteria:

1. Patient-related criteria:

• Severe congestive heart failure[LVEF <30% or NYHA( New York Heart Association) III/IV)]

• Severe valvular heart disease;

• Pregnant or breastfeeding women;

• Life expectancy no more than 1 year or factors causing difficulties in clinical follow up;

• Bleeding predisposition, contraindications of anticoagulants or antiplatelet agents;

• Intorerance to aspirin and/or clopidogrel or other anti platelet drugs;

• Leukopenia or thrombopenia;

• Stroke within 6 months prior to the operation;

• A history of severe hepatic or renal failure.

2. Lesion-related criteria :

• Ostia lesions of left main or right coronary artery;

• Percutaneous coronary intervention of the graft vessel;

• Lesions that are not indications of PTCA(percutaneous transluminal coronary angiography) or other intervention therapy.

Related Conditions & MeSH terms

• Coronary Disease

Intervention

Device:
• Paclitaxel DCB
The length of the DCB catheter should be chosen to exceed the target lesion for at least 2mm (at both proximal and distalends). The catheter(s) will be inflated for 30 to 60s with a minimum of 7 atm. Predilation of the diseased coronary segment with a uncoated balloon/scoring balloon/cutting balloon before the use of DCB will be encouraged. DES should be implanted if the angiographic result after DCB alone therapy is not satisfactory due to significant recoil/residual stenosis or dissection (Type C-F).

Locations

Country	Name	City	State
China	Beijing Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Ann SH, Her AY, Singh GB, Okamura T, Koo BK, Shin ES. Serial Morphological and Functional Assessment of the Paclitaxel-coated Balloon for de Novo Lesions. Rev Esp Cardiol (Engl Ed). 2016 Nov;69(11):1026-1032. doi: 10.1016/j.rec.2016.03.026. Epub 2016 Jun 16. English, Spanish. — View Citation

Nishiyama N, Komatsu T, Kuroyanagi T, Fujikake A, Komatsu S, Nakamura H, Yamada K, Nakahara S, Kobayashi S, Taguchi I. Clinical value of drug-coated balloon angioplasty for de novo lesions in patients with coronary artery disease. Int J Cardiol. 2016 Nov 1;222:113-118. doi: 10.1016/j.ijcard.2016.07.156. Epub 2016 Jul 27. — View Citation

Shin ES, Ann SH, Balbir Singh G, Lim KH, Kleber FX, Koo BK. Fractional flow reserve-guided paclitaxel-coated balloon treatment for de novo coronary lesions. Catheter Cardiovasc Interv. 2016 Aug;88(2):193-200. doi: 10.1002/ccd.26257. Epub 2015 Oct 1. — View Citation

Yu X, Ji F, Xu F, Zhang W, Wang X, Lu D, Yang C, Wang F. Treatment of large de novo coronary lesions with paclitaxel-coated balloon only: results from a Chinese institute. Clin Res Cardiol. 2019 Mar;108(3):234-243. doi: 10.1007/s00392-018-1346-8. Epub 2018 Aug 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of net adverse cardiac events (NACEs) at 24 months after DCB treatment.	A composite endpoint of NACEs, including cardiovascular death, myocardial infarction, target lesion revascularization, target vessel revascularization, stroke, all cause bleeding.	Clinical follow-up at 24 months after the procedure.
Secondary	Late lumen loss(LLL) at 24 months follow-up	LLL is defined as minimal lumen diameter(MLD) at follow-up minus MLD immediately post the procedure according to QCA.	Coronary angiography follow-up at 24 months after the procedure.