The Clinical Efficacy and Safety of Drug-coated Balloon

Coronary Heart Disease Clinical Trial

Official title:

The Clinical Efficacy and Safety of Drug-coated Balloon in Coronary Lesions: a Real-World, All-Comers ,Single-center, Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05133921
• Other study ID #: CAGE-FREE registry
• Status: Completed
• Start date: December 1, 2015
• Est. completion date: December 1, 2020

Study information

• Verified date: January 2024
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2487
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Angioplasty, Balloon
• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Locations

Country	Name	City	State
China	Ling Tao	Xi'an	Shannxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	POCE	POCE is a composite clinical endpoint of all-cause death, any stroke, non-fatal myocardial infarction (MI), any revascularization	1 or 12 months
Other	All-cause death	Rates of individual components of PoCE	1, 12, or 24 months
Other	Non-fatal myocardial infarction (MI)	Rates of individual components of PoCE	1, 12, or 24 months
Other	Any stroke	Rates of individual components of PoCE	1, 12, or 24 months
Other	Any revascularization	Rates of individual components of PoCE	1, 12, or 24 months
Other	Device-oriented Composite Endpoint (DoCE)	DoCE is a composite clinical endpoint of cardiac death, target vessel myocardial infraction (TV-MI), and Clinically individual target lesion revascularization (CI-TLR)	1, 12, or 24 months
Other	Cardiac death	Rates of individual components of DoCE	1, 12, or 24 months
Other	Target vessel myocardial infraction (TV-MI)	Rates of individual components of DoCE	1, 12, or 24 months
Other	Clinically individual target lesion revascularization (CI-TLR)	Rates of individual components of DoCE	1, 12, or 24 months
Other	Target vessel failure (TVF)	Target vessel failure is defined as cardiovascular death, target vessel myocardial infraction (TV-MI), and clinically-indicated target vessel revascularization	1, 12, or 24 months
Other	Clinically-indicated target vessel revascularization	Rates of individual components of TVF	1, 12, or 24 months
Other	BARC type 3 or 5 bleeding events	Bleeding events type 3 or 5 defined by BARC (Bleeding Academic Research Consortium) criteria	1, 12, or 24 months
Other	Net adverse clinical events (NACE)	NACE is a composite clinical endpoint of all-cause death, any stroke, any any non-fatal myocardial infarction ( MI) any revascularization and BARC type 3 or 5 bleeding events	1, 12, or 24 months
Other	Vessel-oriented Composite Endpoint (VOCE)	VOCE is a composite clinical endpoint of Vessel-related cardiovascular Death, Target-vessel related MI, Clinically-oriented Target vessel revascularization	1, 12, or 24 months
Other	Vessel-related cardiovascular Death	Rates of individual components of VOCE	1, 12, or 24 months
Primary	Patient-oriented Composite Endpoint (PoCE)	POCE is a composite clinical endpoint of all-cause death, any stroke, any non-fatal myocardial infarction (MI), any revascularization	24 months