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

January 22, 2026 updated by: Ling Tao, MD, PhD, Xijing Hospital

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

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shannxi
      • Xi'an, Shannxi, China, 710032
        • Recruiting
        • Xijing Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: Before discharge
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
Time Frame: Before discharge
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
Time Frame: Before discharge
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
Time Frame: Before discharge
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
Time Frame: Before discharge
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
Time Frame: Before discharge
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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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