NCT07378163 Study on the Preferences for PCI Implantation Devices Among Doctors and Patients
| NCT ID | NCT07378163 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xijing Hospital |
| Condition | Coronary Artery Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2025-08-18 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2025-08-18 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Ling Tao, M.D., Ph.D
STUDY CHAIR
Xijing Hospital
Frequently Asked Questions
Who can join the NCT07378163 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07378163 currently recruiting?
Yes, NCT07378163 is actively recruiting participants. Contact the research team at Woshigaochao@gmail.com for enrollment information.
Where is the NCT07378163 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT07378163 clinical trial?
NCT07378163 is sponsored by Xijing Hospital. The principal investigator is Ling Tao, M.D., Ph.D at Xijing Hospital. The trial plans to enroll 600 participants.