Doctors' and patients' preferences for PCI implantation devices
Study on the Preferences for Percutaneous Coronary Intervention Implantation Devices Among Healthcare Providers and Patients With Coronary Artery Disease
This questionnaire tests what patients who have had PCI and the doctors who treat them prefer between drug-eluting stents and drug-coated balloons.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Xijing Hospital Academic / other |
| Locations | 1 site (Xi'an, Shannxi) |
| Trial ID | NCT07378163 on ClinicalTrials.gov |
What this trial studies
Contemporary PCI typically uses balloon lesion preparation followed by a drug-eluting stent (DES) to scaffold the vessel and reduce restenosis, while drug-coated balloons (DCB) deliver antiproliferative drug without leaving a metallic scaffold. DCBs are established for in-stent restenosis and small vessels, but the REC-CAGEFREE I trial found a DCB-first strategy with rescue stenting did not meet non-inferiority versus planned DES in de novo, non-complex coronary disease. This observational study uses questionnaires administered at Xijing Hospital to capture preferences from patients who have undergone PCI and from healthcare providers who treat coronary artery disease. The goal is to map attitudes toward device choice to inform shared decision-making and future device-use strategies.
Who should consider this trial
Good fit: Ideal participants are adults who have acute or chronic coronary syndrome and have undergone PCI and can complete the questionnaire, as well as healthcare providers who treat coronary artery disease.
Not a fit: People under 18, those unable to understand the questionnaire or with cognitive impairment, and individuals who have not undergone PCI are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could help align device selection with patient values and inform clinician decision-making to potentially reduce unnecessary stent use.
How similar studies have performed: Prior trials show DCBs are effective for in-stent restenosis and small vessels, but REC-CAGEFREE I reported a DCB-with-rescue-stent strategy did not demonstrate non-inferiority compared with intended DES for de novo non-complex CAD.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Xi'an, Shannxi
- Xijing Hospital — Xi'an, Shannxi, China (Recruiting)
Study contacts
- Study coordinator: Ruining Zhang, BSc
- Email: Woshigaochao@gmail.com
- Phone: +8618629551066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.