Clinical trial NCT03817801: Comparison of Scoring Balloon and Conventional Balloon Predilation Before Drug Coated Balloon for de Novo Lesion in Patients With High Bleeding Risk
Official title: Comparison of Scoring Balloon and Conventional Balloon Predilation Before Drug Coated Balloon for de Novo Lesion in Patients With High Bleeding Risk: A Randomized, Single-center, Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-01-28
Enrollment: 60
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).

Detailed description: This is a pilot study that aim to enroll 60 subjects with high bleeding risk.

All patients with coronary artery stenosis suitable for DCB treatment will undergo 1:1 randomization either to NSE predilation or NC balloon predilation using a randomization schedule.

All subjects will be screened according to the predefined inclusion and exclusion criteria per protocol and will further undergo IVUS before DCB treatment. Data and images will be collected during the index procedure, and at the predefined 6-month IVUS follow-up visit.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The absolute change in minimal lumen area (MLA)
timeFrame: 6 months
Secondary outcomes:
measure: Bailout drug-eluting stents (DES) implantation rate
timeFrame: During procedure
measure: Fractional Flow Reserve (FFR) value
timeFrame: immediately after balloon predilation
measure: Minimum lumen area (MLA)
timeFrame: immediately after procedure
measure: Minimum lumen diameter (MLD)
timeFrame: immediately after procedure
measure: Plaque burden
timeFrame: immediately after procedure
measure: Dissection
timeFrame: immediately after procedure
measure: Atheroma volume
timeFrame: immediately after procedure
measure: The diameter stenosis of target lesion
timeFrame: 6 months
measure: The late lumen loss of target lesion
timeFrame: 6 months
measure: The binary restenosis of target lesion
timeFrame: 6 months
measure: The composite of cardiac death, myocardial infarction, target lesion revascularization (TLR), and target lesion thrombosis
timeFrame: 6 months
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Shao-Liang Chen, MD, PhD
role: STUDY_CHAIR
References: