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
Verified date | January 2024 |
Source | Xijing Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Ling Tao | Xi'an | Shannxi |
Lead Sponsor | Collaborator |
---|---|
Xijing Hospital |
China,
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 |
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