Study on the Preferences for PCI Implantation Devices Among Doctors and Patients (REC-DEVICEPREF)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention
• Intervention / Treatment: Other: Questionnaire

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Ruining Zhang, BSc; Phone Number: +8618629551066; Email: Woshigaochao@gmail.com

Study Locations

• China
  • Shannxi
    • Xi'an, Shannxi, China, 710032
      • Recruiting
      • Xijing Hospital
      • Contact: Shutong Li, MBBS; Phone Number: 13379338216; Email: shutongli@fmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Healthcare providers and patients with CAD

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects; Medical staff and patients with CAD	Other: Questionnaire; A questionnaire regarding the preference of DCB or DES-based PCI among patients with CAD and medical staff

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Study Chair: Ling Tao, M.D., Ph.D, Xijing Hospital; Study Chair: Chao Gao, M.D., Ph.D, Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: January 22, 2026
• First Posted (Actual): January 30, 2026

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Coronary artery disease; drug-coated balloon; drug-eluting stent
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: REC-DEVICEPREF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No