Clinical trial NCT05133921: The Clinical Efficacy and Safety of Drug-coated Balloon
Official title: The Clinical Efficacy and Safety of Drug-coated Balloon in Coronary Lesions: a Real-World, All-Comers ,Single-center, Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Heart Disease
Angioplasty, Balloon
Keywords: Drug-coated balloons
De-novo
All-comers
In-stent stenosis
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2021-11-24
Enrollment: 2487
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who received PCI with one or more drug-coated balloons (DCB) in the Xijing hospital of the Air Force Medical University from December 1, 2015 to December 1, 2019.

Brief summary: Drug-Coated Balloon (DCB) angioplasty is similar to plain old balloon angioplasty procedurally, but there is an anti-proliferative medication paclitaxel coated on the balloon. Treating in-stent restenosis (ISR) with the DCB has the theoretical advantage of avoiding multiple stent layers and respecting the vessel anatomy. DCB has shown promising results for the treatment of ISR. Currently, DCB has a Class I indication to treat ISR recommended by European Society of Cardiology (ESC) guidelines. In addition, some interventional cardiologist has also applied DCB in de novo lesions in their clinical practice.

Although some small sample size RCTs and observational studies have suggested that the clinical prognosis of DCB in primary large vessels is non-inferior to drug-eluting stent (DES), there is no large-scale RCT or cohort studies to compare the clinical effects of DCB and DES.

Despite several theoretical benefits of DCB, the procedural-related complications cannot be entirely prevented, such as acute elastic retraction and severe dissection, which would affect coronary blood flow or lead to acute vascular occlusion.

Some studies have suggested that optimization of the procedural technique can reduce the occurrence of complications and target lesion failure in the long-term. Proposed criteria include adapting cutting or scoring balloon for pre-dilatation, residual stenosis\<30% post-DCB, maintaining TIMI flow=3, DCB dilation time\<60s, and appropriate balloon to vessel ratio\> 0.91. However, such proposed technique and criteria have not been evaluated in the real-world clinical practice.

This current study is designed to investigate the efficacy and safety of DCB in the real world and exploring the optimal procedural configurations.


Eligibility criteria: Inclusion Criteria:

1. Patients who received PCI with one or more drug-coated balloons (DCB)
2. Patients who did not received drug-eluting stent implantation

Exclusion Criteria:

1. Currently participating in another trial or participants unable to comply to follow-up

Primary outcomes:
measure: Patient-oriented Composite Endpoint (PoCE)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
measure: POCE
timeFrame: 1 or 12 months
measure: All-cause death
timeFrame: 1, 12, or 24 months
measure: Non-fatal myocardial infarction (MI)
timeFrame: 1, 12, or 24 months
measure: Any stroke
timeFrame: 1, 12, or 24 months
measure: Any revascularization
timeFrame: 1, 12, or 24 months
measure: Device-oriented Composite Endpoint (DoCE)
timeFrame: 1, 12, or 24 months
measure: Cardiac death
timeFrame: 1, 12, or 24 months
measure: Target vessel myocardial infraction (TV-MI)
timeFrame: 1, 12, or 24 months
measure: Clinically individual target lesion revascularization (CI-TLR)
timeFrame: 1, 12, or 24 months
measure: Target vessel failure (TVF)
timeFrame: 1, 12, or 24 months
measure: Clinically-indicated target vessel revascularization
timeFrame: 1, 12, or 24 months
measure: BARC type 3 or 5 bleeding events
timeFrame: 1, 12, or 24 months
measure: Net adverse clinical events (NACE)
timeFrame: 1, 12, or 24 months
measure: Vessel-oriented Composite Endpoint (VOCE)
timeFrame: 1, 12, or 24 months
measure: Vessel-related cardiovascular Death
timeFrame: 1, 12, or 24 months
Locations:
city: Xi'an
country: China
facility: Ling Tao
state: Shannxi
Study officials:
affiliation: Xijing Hospital
name: Ling Tao, MD, Ph.D.
role: STUDY_CHAIR
affiliation: Xijing Hospital
name: Chao Gao, MD, Ph.D.
role: STUDY_CHAIR
References: