Comparison of Scoring Balloon and Conventional Balloon Predilation Before Drug Coated Balloon for de Novo Lesion in Patients With High Bleeding Risk

NCT03817801 | Completed DMC

• 1 other identifier: NFH20190104
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to investigate whether scoring balloon (non-slip element, NSE) predilation compared to non-compliant (NC) balloon predilation for de novo lesion in patients with high bleeding risk and planning to receive drug-coated balloon (DCB) treatment will lead to lower change in minimal lumen area (MLA) at 6 months by intravascular ultrasound (IVUS).

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• The absolute change in minimal lumen area (MLA)

  The absolute change in MLA from post-procedure to 6-month follow-up identified by intravascular ultrasound (IVUS)

  6 months

Secondary Outcomes (11)

• Bailout drug-eluting stents (DES) implantation rate

  During procedure

• Fractional Flow Reserve (FFR) value

  immediately after balloon predilation

• Minimum lumen area (MLA)

  immediately after procedure

• Minimum lumen diameter (MLD)

  immediately after procedure

• Plaque burden

  immediately after procedure

Study Arms (2)

non-slip element (NSE) predilation

EXPERIMENTAL

In the NSE predilation group, NSE predilation will be performed for all lesions preparation before drug-coated balloon (DCB) treatment.

Device: NSE balloon

non-compliant (NC) balloon predilation

ACTIVE COMPARATOR

In the NC balloon predilation group, NC balloon predilation will be performed for all lesions preparation before DCB treatment.

Device: NC balloon

Interventions

NSE balloon DEVICE

NSE (Goodman®) predilation + DCB (Sequent® Please) treatment

non-slip element (NSE) predilation

NC balloon DEVICE

NC balloon predilation + DCB (Sequent® Please) treatment

non-compliant (NC) balloon predilation

Eligibility Criteria

• Age: Up to 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• De Novo lesion, suitable for intravascular ultrasound (IVUS) and fractional flow reserve (FFR) test;
• Coronary artery disease (CAD) patients with high risk of bleeding

You may not qualify if:

• Previous coronary artery bypass graft (CABG) patients
• Stent implantation in the target vessel
• Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2
• Acute ST segment elevation myocardial infarction (STEMI) within 48 hours
• Contraindications to contrast media, antiplatelet therapy, or paclitaxel
• Cardiac shock
• Pregnancy
• Expected life less than 12 months

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

Location

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, PhD

  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 are released.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Director of Cardiovascular Department

Model Details: Patients will undergo 1:1 randomization to either non-slip element (NSE) predilation which will be the treatment group or non-compliant (NC) balloon predilation which will be the control group. The initiation of the trial is defined as the time of randomization. After study subjects' enrollment and randomization, the study intervention will take place immediately. The follow-up visits for the primary endpoint are scheduled at 1and 6 months after the index procedure.

Study Record Dates

• First Submitted: January 21, 2019
• First Posted: January 28, 2019
• Study Start: July 30, 2019
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)