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Recruiting NCT07378163

Study on the Preferences for PCI Implantation Devices Among Doctors and Patients

— Observational Coronary Artery Disease Percutaneous Coronary Intervention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Questionnaire.
Who it may be relevant to
Registry conditions: Coronary Artery Disease, Percutaneous Coronary Intervention. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Study on the Preferences for Percutaneous Coronary Intervention Implantation Devices Among Healthcare Providers and Patients With Coronary Artery Disease

Overview

The contemporary percutaneous treatment of coronary artery disease typically involves initial lesion preparation with balloon angioplasty, followed by the deployment of a drug-eluting stent (DES) to provide an immediate scaffold and reduce the long-term risk of restenosis. However, stent implantation continues to present notable challenges, primarily due to the metallic scaffold left behind. Compared to DES, drug-coated balloons (DCB) provide a direct release of antiproliferative drugs into the vessel wall, preventing coronary restenosis after angioplasty and limiting the risk of stent-related events. DCBs are an established treatment option for in-stent restenosis and small vessels. However, the REC-CAGEFREE I trial demonstrated that a strategy of DCB angioplasty with rescue stenting did not achieve non-inferiority compared with the intended DES implantation in patients with de novo, non-complex coronary artery disease (CAD), irrespective of vessel diameter. Previous studies have mainly focused on the efficacy of PCI strategies in reducing adverse event rates, while less attention has been paid to patients' willingness regarding stent implantation. The AHA conducted a systematic review on depression and poor prognosis among patients with acute coronary syndrome (ACS), concluding that health organizations should consider depression as an official risk factor for poor prognosis after ACS. A prior study of patients with coronary artery disease after stent implantation found that their anxiety stemmed primarily from concerns about the stent's long-term effects and its impact on their social interaction. However, data regarding patients' preferences on the selection of DES or DCB is scarce, and whether the psychological impact would differ between DES- or DCB-treated patients is still unknown. This study aimed to investigate the preferences of patients, as well as medical staff, for DES or DCB-based PCI.

Interventions

  • Other Questionnaire
    A questionnaire regarding the preference of DCB or DES-based PCI among patients with CAD and medical staff

Primary outcome measures

  • Maximum acceptable risk in the trade-off of death [Time frame: Before discharge]
  • Maximum acceptable risk in the trade-off of stroke [Time frame: Before discharge]
  • Maximum acceptable risk in the trade-off of myocardial infarction [Time frame: Before discharge]
  • Maximum acceptable risk in the trade-off of cardiopulmonary resuscitation [Time frame: Before discharge]
  • Maximum acceptable risk in the trade-off of revascularization [Time frame: Before discharge]
  • Maximum acceptable risk in the trade-off of rehospitalization [Time frame: Before discharge]

Eligibility criteria

Inclusion criteria

  • Patients with acute or chronic coronary syndrome who have undergone percutaneous coronary intervention;
  • Patients who can understand the purpose of this trial and are willing to participate in the preference questionnaire.
  • Healthcare providers who treat patients with coronary artery disease.

Exclusion criteria

  • Aged < 18 years;
  • Inability to understand the questionnaire or presence of cognitive impairment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Xijing Hospital — Xi'an

Identifiers

NCT: NCT07378163 · REC-DEVICEPREF

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗