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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07378163

Acronym

REC-DEVICEPREF

Enrollment

600

Registered

2026-01-30

Start date

2025-08-18

Completion date

2026-03-01

Last updated

2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease, Percutaneous Coronary Intervention

Keywords

Coronary artery disease, drug-coated balloon, drug-eluting stent

Brief summary

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

OTHERQuestionnaire

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Patients with acute or chronic coronary syndrome who have undergone percutaneous coronary intervention; 2. Patients who can understand the purpose of this trial and are willing to participate in the preference questionnaire. 3. Healthcare providers who treat patients with coronary artery disease.

Exclusion criteria

1. Aged \< 18 years; 2. Inability to understand the questionnaire or presence of cognitive impairment.

Design outcomes

Primary

Measure	Time frame	Description
Maximum acceptable risk in the trade-off of death	Before discharge	To avoid permanent metallic stent implantation, the maximum acceptable increase in risk for patients and medical staff in choosing DCB treatment.
Maximum acceptable risk in the trade-off of stroke	Before discharge	To avoid permanent metallic stent implantation, the maximum acceptable increase in risk for patients and medical staff in choosing DCB treatment.
Maximum acceptable risk in the trade-off of myocardial infarction	Before discharge	To avoid permanent metallic stent implantation, the maximum acceptable increase in risk for patients and medical staff in choosing DCB treatment.
Maximum acceptable risk in the trade-off of cardiopulmonary resuscitation	Before discharge	To avoid permanent metallic stent implantation, the maximum acceptable increase in risk for patients and medical staff in choosing DCB treatment.
Maximum acceptable risk in the trade-off of revascularization	Before discharge	To avoid permanent metallic stent implantation, the maximum acceptable increase in risk for patients and medical staff in choosing DCB treatment.
Maximum acceptable risk in the trade-off of rehospitalization	Before discharge	To avoid permanent metallic stent implantation, the maximum acceptable increase in risk for patients and medical staff in choosing DCB treatment.

Countries

China

Contacts

CONTACTRuining Zhang, BSc

Woshigaochao@gmail.com+8618629551066

STUDY_CHAIRLing Tao, M.D., Ph.D

Xijing Hospital

STUDY_CHAIRChao Gao, M.D., Ph.D