Intravascular Ultrasound Versus Angiography Guided Drug-coated Balloon

NCT04255043 | Completed DMC

• 1 other identifier: KY20200110-02
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

Drug-coated balloon (DCB) is an alternative choice for denovo lesions in coronary artery disease patients with high bleeding risk. Intravascular ultrasound (IVUS) can provide more details of coronary anatomy and stent implantation, overcoming a number of limitations of coronary angiography. However, the benefit of IVUS-guided DCB treatment has not been investigated. This study is designed to compare IVUS-guided and Angiography-guided DCB treatment for coronary denovo lesions in patients with high bleeding risk.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• late lumen loss (LLL) at 7 months after procedure

  LLL is defined as the difference between postprocedural minimal lumen diameter (MLD) minus MLD at the time of angiographic follow-up

  7 months

Secondary Outcomes (2)

• Target vessel failure (TVF) at 6 months

  6 months

• bleeding at 6 months

  6 months

Study Arms (2)

IVUS-guided DCB

EXPERIMENTAL

In the IVUS guidance group, IVUS assessment will be used before procedure, post-procedure, and at the follow-up.

Device: IVUS guidance

Angiography-guided DCB

ACTIVE COMPARATOR

In the Angiography guidance group, DCB treatment will be guided by routine coronary angiography.

Device: Angiography guidance

Interventions

IVUS guidance DEVICE

IVUS (Boston Scientific®) guidance + DCB (Sequent® Please) treatment

IVUS-guided DCB

Angiography guidance DEVICE

DCB (Sequent® Please) treatment

Angiography-guided DCB

Eligibility Criteria

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

You may qualify if:

• De novo lesions, suitable for DCB treatment.
• Patients with high bleeding risk.

You may not qualify if:

• Target lesion length \> 15mm.
• Severe calcified lesions.
• Left main disease.
• Ostial lesions.
• Three-vessel disease.
• Acute myocardial infarction within 48 hours.
• Target vessel received stent implantation.
• Hemodynamic instability.

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, China

Location

Related Publications (1)

• Gao XF, Ge Z, Kong XQ, Chen X, Han L, Qian XS, Zuo GF, Wang ZM, Wang J, Song JX, Lin L, Pan T, Ye F, Wang Y, Zhang JJ, Chen SL; ULTIMATE Ⅲ Investigators. Intravascular Ultrasound vs Angiography-Guided Drug-Coated Balloon Angioplasty: The ULTIMATE Ⅲ Trial. JACC Cardiovasc Interv. 2024 Jul 8;17(13):1519-1528. doi: 10.1016/j.jcin.2024.04.014. Epub 2024 Jun 5.

  PMID: 38842991 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Shao-Liang Chen, MD

  Nanjing First Hospital, Nanjing Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will remain blinded until the final study results released.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice chief of the department of cardiology

Model Details: All subjects will undergo 1:1 randomization to either IVUS or Angiography-guided DCB treatment for coronary denovo lesions in patients with high bleeding risk.

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: February 5, 2020
• Study Start: February 3, 2020
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)