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Coronary DiseaseDCB-denovoNCT04022200

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

An observational study of Coronary Disease, run by Beijing Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Disease
What is being tested?
Paclitaxel DCB
Type of treatment
Medical device
How many people
300 participants
Where
1 siteChina
Study dates
1 Aug 2019to 31 Jul 2023
How long will I take part?
24 Months
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 14Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

Xue Yu, MD contact

00861085132266 ext. 2535

yuxuemd@aliyun.com

Peng Li, MD contact

00861085132266 ext. 2535

lipeng4513@bjhmoh.cn

China1 site, 1 recruiting

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

    Xin Wang, Dr., 00861058115037, bjyygcp@126.com

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Paclitaxel DCB
Keywords
drug-coated balloon, angioplasty, de novo lesions
Medical subject headings
Coronary Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paclitaxel DCBDevice

    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 in NCT04022200
Study groupRoleWhat they receive
Paclitaxel DCB for De Novo Coronary Lesionswe define de novo coronary artery lesions as the lesions never been treated with any interventional device, such as POBA, stent, rota ablation, laser etc.
Receives: Device: Paclitaxel DCB

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Clinical follow-up at 24 months after the procedure.

Secondary outcomes (1)

  1. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2019
  2. Study start1 Aug 2019
  3. Primary completion31 Jan 2023 (estimated)
  4. Study completion31 Jul 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
Target duration
24 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT04022200
Sponsor's protocol ID
BJH DCB for de novo
Acronym
DCB-denovo
Status last verified
Mar 2022
First submitted
14 Jul 2019
Last updated
22 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 30074078

  • 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.

    PubMed 27321644

  • 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.

    PubMed 27494722

  • 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.

    PubMed 26423017

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Disease, run by Beijing Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xue Yu, MD (00861085132266 ext. 2535, yuxuemd@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04022200, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.

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