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

NCT04022200 | Unknown

• 1 other identifier: BJH DCB for de novo
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Disease

Keywords

drug-coated balloon; angioplasty; de novo lesions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Late lumen loss(LLL) at 24 months follow-up

  Coronary angiography follow-up at 24 months after the procedure.

Study Arms (1)

Paclitaxel DCB for De Novo Coronary Lesions

we define de novo coronary artery lesions as the lesions never been treated with any interventional device, such as POBA, stent, rota ablation, laser etc.

Device: Paclitaxel DCB

Interventions

Paclitaxel DCB DEVICE

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).

Paclitaxel DCB for De Novo Coronary Lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stable angina, unstable angina, myocardial infarction or evidence of asymptomatic myocardial ischemia and consent to receive coronary intervention therapy. They will receive clinical follow up at 30 days, 3, 6, 12 and 24 months after procedure and one angiographic follow up at 24 months after procedure.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Beijing Hospital: lead

Study Sites (1)

Beijing Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 30074078 BACKGROUND

• 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.

  PMID: 27321644 BACKGROUND

• 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.

  PMID: 27494722 BACKGROUND

• 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.

  PMID: 26423017 BACKGROUND

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Xue Yu, MD

  Beijing Hospital

  STUDY CHAIR

Central Study Contacts

Xue Yu, MD

CONTACT

00861085132266; yuxuemd@aliyun.com

Peng Li, MD

CONTACT

00861085132266; lipeng4513@bjhmoh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of Cardiology Department

Study Record Dates

• First Submitted: July 14, 2019
• First Posted: July 17, 2019
• Study Start: August 1, 2019
• Primary Completion: January 31, 2023
• Study Completion: July 31, 2023
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)