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

NCT07378163 | Recruiting DMC

• 1 other identifier: REC-DEVICEPREF
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Percutaneous Coronary Intervention

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

Subjects

Medical staff and patients with CAD

Other: Questionnaire

Interventions

Questionnaire OTHER

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

Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthcare providers and patients with CAD

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shannxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ling Tao, M.D., Ph.D

  Xijing Hospital

  STUDY CHAIR

• Chao Gao, M.D., Ph.D

  Xijing Hospital

  STUDY CHAIR

Central Study Contacts

Ruining Zhang, BSc

CONTACT

+8618629551066; Woshigaochao@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Cardiology, Director of the Department of Cardiology

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 30, 2026
• Study Start: August 18, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

CN (1)