Health TrialsbyHealthPanel

Drug Coated Balloon vs. Drug-eluting Stent in Patients With Coronary Artery Disease

ConditionsCoronary Artery DiseasePercutaneous Coronary Intervention (PCI)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorSamsung Medical Center

About this trial

Studies exploring the feasibility of drug-eluting balloon (DCB) in de-novo coronary lesions are limited. There are scarce data comparing DCB with drug-eluting stent (DES) in patients with high bleeding risk (HBR), a situation in which long-term maintenance of dual antiplatelet therapy (DAPT) is a clinical dilemma. This target trial emulation aims to compare clinical outcomes between DCB angioplasty and conventional DES implantation in de-novo coronary lesions in patients with coronary artery disease.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with coronary artery disease undergoing percutaneous coronary intervention

Used devices number less than three (relatively simple lesion)

Disqualifiers

Hybrid strategy (DCB and DES use)

Failed percutaneous coronary intervention

Previous revascularization procedure before index percutaneous coronary intervention

Trial population

Patients with de novo coronary artery disease for relatively simple lesions undergoing percutaneous coronary intervention

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Drug coated balloon

    Device

    Patients receiving drug coated balloon angioplasty for de novo coronary artery disease

  • Drug-eluting stent

    Device

    Patients receiving drug-eluting stent implantationfor de novo coronary artery disease

Treatment groups

470,000 Participants
are divided into 2 treatment groups
Group A: Drug coated balloon1 intervention
Group B: Drug-eluting stent1 intervention

Trial outcomes

Primary outcomes

1

Rates of MACCE (major adverse cardiac and cerebrovascular events)

all-cause death, myocardial infarction, revascularization, and stroke

Time frame
3 years after index procedure

Secondary outcomes

1

Rates of Major bleeding

major bleeding requiring transfusion

Time frame
3 years after index procedure
2

Rates of NACE (net adverse clinical events)

MACCE and any major bleeding requiring transfusion

Time frame
3 years after index procedure
3

Rates of all-cause death

death from any causes

Time frame
3 years after index procedure
4

Rates of myocardial infarction

Time frame
3 years after index procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Samsung Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: