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出境医 / 临床实验 / Angioplasty With Paclitaxel-coated Balloon Only Strategy for Coronary de Novo Lesions (DCB-denovo)

Angioplasty With Paclitaxel-coated Balloon Only Strategy for Coronary de Novo Lesions (DCB-denovo)

Study Description
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.

Condition or disease Intervention/treatment
Coronary Disease Device: Paclitaxel DCB

Detailed 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.
Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: Long Term Clinical Outcomes of Angioplasty With Paclitaxel-coated Balloon Only Strategy for Coronary de Novo Lesions: a Single Center Registry Study
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : July 31, 2023
Arms and Interventions
Group/Cohort Intervention/treatment
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
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).
Outcome Measures
Primary Outcome Measures :
  1. The rate of net adverse cardiac events (NACEs) at 24 months after DCB treatment. [ Time Frame: Clinical follow-up at 24 months after the procedure. ]
    A composite endpoint of NACEs, including cardiovascular death, myocardial infarction, target lesion revascularization, target vessel revascularization, stroke, all cause bleeding.


Secondary Outcome Measures :
  1. Late lumen loss(LLL) at 24 months follow-up [ Time Frame: Coronary angiography follow-up at 24 months after the procedure. ]
    LLL is defined as minimal lumen diameter(MLD) at follow-up minus MLD immediately post the procedure according to QCA.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Xue Yu, MD 00861085132266 ext 2535 yuxuemd@aliyun.com
Contact: Peng Li, MD 00861085132266 ext 2535 lipeng4513@bjhmoh.cn

Locations
Layout table for location information
China, Beijing
Beijing Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Xin Wang, Dr.    00861058115037    bjyygcp@126.com   
Sponsors and Collaborators
Beijing Hospital
Investigators
Layout table for investigator information
Study Chair: Xue Yu, MD Beijing Hospital
Tracking Information
First Submitted Date July 14, 2019
First Posted Date July 17, 2019
Last Update Posted Date January 28, 2021
Actual Study Start Date August 1, 2019
Estimated Primary Completion Date January 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 30, 2019) 		The rate of net adverse cardiac events (NACEs) at 24 months after DCB treatment. [ Time Frame: Clinical follow-up at 24 months after the procedure. ]
A composite endpoint of NACEs, including cardiovascular death, myocardial infarction, target lesion revascularization, target vessel revascularization, stroke, all cause bleeding.
Original Primary Outcome Measures
 (submitted: July 14, 2019) 		TLR rate at 9 months follow-up [ Time Frame: Follow-up coronary angiography at 9 months after the procedure ]
TLR is defined as any repeat revascularization (percutaneous or surgical) secondary to a stenosis >50% within the stent or within 5mm proximal or distal to the stented segment.
Change History
Current Secondary Outcome Measures
 (submitted: July 30, 2019) 		Late lumen loss(LLL) at 24 months follow-up [ Time Frame: Coronary angiography follow-up at 24 months after the procedure. ]
LLL is defined as minimal lumen diameter(MLD) at follow-up minus MLD immediately post the procedure according to QCA.
Original Secondary Outcome Measures
 (submitted: July 14, 2019) 		the rate of major adverse cardiac events (MACEs) [ Time Frame: Clinical follow up at 30 days, 6, 9, 12 and 24 months after the procedure ]
a composite of cardiovascular (CVS) death, target vessel related myocardial infarction (MI), and TLR.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Angioplasty With Paclitaxel-coated Balloon Only Strategy for Coronary de Novo Lesions
Official Title Long Term Clinical Outcomes of Angioplasty With Paclitaxel-coated Balloon Only Strategy for Coronary de Novo Lesions: a Single Center Registry Study
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.
Detailed 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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 24 Months
Biospecimen Not Provided
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.
Condition 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).
Study Groups/Cohorts 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.
Intervention: Device: Paclitaxel DCB
Publications *
  • 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.
  • 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 14, 2019) 		300
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 31, 2023
Estimated Primary Completion Date January 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Xue Yu, MD 00861085132266 ext 2535 yuxuemd@aliyun.com
Contact: Peng Li, MD 00861085132266 ext 2535 lipeng4513@bjhmoh.cn
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04022200
Other Study ID Numbers BJH DCB for de novo
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Xue Yu, Beijing Hospital
Study Sponsor Beijing Hospital
Collaborators Not Provided
Investigators
Study Chair: Xue Yu, MD Beijing Hospital
PRS Account Beijing Hospital
Verification Date January 2021

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