Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05133921
Other study ID # CAGE-FREE registry
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Completed NCT05088291 - Application of a New X-ray Protective Device in Coronary Interventional Therapy
Completed NCT03076801 - Does Choral Singing Help imprOve Stress in Patients With Ischemic HeaRt Disease? N/A
Completed NCT04584645 - A Digital Flu Intervention for People With Cardiovascular Conditions N/A
Not yet recruiting NCT04995159 - Optimized Antiplatelet Therapy in Patients With CHD After Implantation of NeoVas™ BRS System N/A
Recruiting NCT02967718 - Innovation Research of Differentiation and Treatment Methods Based on CHD Phlegm and Blood Stasis Syndrome N/A
Completed NCT02888652 - Study on the Registration of Coronary Heart Disease Patients Undergoing PCI
Terminated NCT02045134 - Supplementation With Polyphenol-Rich Foods and Atrial Fibrillation After a Cardiac Surgery N/A
Completed NCT02163044 - The Hellenic Postprandial Lipemia Study (HPLS)
Active, not recruiting NCT02244853 - Heart Rate and Cardiovascular Diseases Prognosis in People With Stable Coronary Artery Disease N/A
Completed NCT01920009 - Impact of Motivational Interviews Within Pharmacy Care Upon Adherence to Cardiovascular Medicines N/A
Completed NCT02440893 - Understanding the Effect of Metformin on Corus CAD (or ASGES)
Terminated NCT01906957 - Cognition and Exercise Training N/A
Completed NCT02753829 - Home-based Cardiovascular Rehabilitation, Maintenance Phase, in Subjects With Coronary Artery Disease N/A
Completed NCT01826552 - Comparison of the Angiographic Result of the Orsiro Hybrid Stent With Resolute Integrity Stent Phase 4
Recruiting NCT01689688 - Healing Response to Everolimus-eluting Stent Implantation; Serial Assessment With opticaL Coherence Tomography N/A
Completed NCT01779401 - Clopidogrel Response Evaluation and AnTi-Platelet InterVEntion in High Thrombotic Risk PCI Patients N/A
Recruiting NCT01456364 - Intracoronary Stenting and Antithrombotic Regimen: ADjusting Antiplatelet Treatment in PatienTs Based on Platelet Function Testing Phase 4
Recruiting NCT01462799 - COR-PRIM: Problem-based Learning (PBL) After Coronary Heart Disease (CHD) - Long-term Evaluation in Primary Care of Self-care N/A
Completed NCT01428947 - Does Coronary Angiography Cause Cognitive Dysfunction? N/A