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NCT Number: NCT04255563

Drug-coating Balloon Treatment in Coronary Artery Disease

Drug-coated balloon (DCB) is an alternative choice for patients with coronary artery disease (CAD). This study is to investigate the efficacy and safety of DCB treatment in patients with CAD.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing First Hospital

Nanjing, Jiangsu, China

Location status: Recruiting

Location contact

Shaoliang Chen, MD

CONTACT

[email protected]

13605157029

About this study

This is a prospective, multi-center, registry to enroll patients undergoing DCB treatment.

All subjects undergoing DCB treatment will be enrolled in this study without strict inclusion and exclusion criteria. Data and images will be collected during the index procedure, and at the clinical and angiographic follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients suitable for DCB treatment

Exclusion criteria

  • Pregnancy
  • Contraindications to contrast media, antiplatelet therapy, or paclitaxel
  • Expected life less than 12 months
  • Cardiac shock

Treatment and study plan

DCB treatment

Device

DCB (Sequent® Please) treatment for CAD patients will be enrolled. Intravascular ultrasound (Boston Scientific®) guidance is recommended.

Primary outcomes

  1. target vessel failure (TVF) at 12 months

    Time frame: 12 months

    TVF is defined as the composite of cardiac death, target-vessel myocardial infarction and ischemia-driven target- vessel revascularization.

Secondary outcomes

  1. Parameter by quantitative coronary angiography at 7 months

    Time frame: 7 months

    Late lumen loss

  2. Bleeding at 12 months

    Time frame: 12 months

    bleeding

  3. Bailout drug-eluting stents (DES) implantation rate

    Time frame: During procedure

    Bailout DES implantation rate during procedure by angiographic criteria

Study contacts

Contact information is provided by the study sponsor or research team.

Jun-Jie Zhang, MD

CONTACT

[email protected]

025-52271350

Xiao-Fei Gao, MD

CONTACT

[email protected]

025-52271350

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

Drug-coating Balloon Treatment in Coronary Artery Disease: a Prospective, Multicenter, Registry Study (ULTIMATE-DCB)

Acronym: ULTIMATE-DCB

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Feb 5, 2020
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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