Publication date context: February 19, 2026. This article reports a not yet recruiting trial by DK Medical Technology to evaluate a coronary artery drug coated balloon dilatation catheter for in stent restenosis and de novo coronary lesions.
DK Medical Technology (Suzhou) Co., Ltd is listed as sponsor. The intervention is a device named Coronary Artery Drug Coated Balloon Dilatation Catheter. The trial scope includes in stent restenosis and de novo lesions in the coronary arteries. The ClinicalTrials.gov identifier is NCT07415902, and the study page is linked below.
Not yet recruiting status indicates that no participant enrollment has begun as of the date shown in the registry.
What changed in the trial status?
The ClinicalTrials.gov entry NCT07415902 shows the study is not yet recruiting. The sponsor listed is DK Medical Technology (Suzhou) Co., Ltd. The protocol describes a device named Coronary Artery Drug Coated Balloon Dilatation Catheter and lists the conditions in in stent restenosis and de novo coronary artery lesions. The page provides a direct link to the study page.
Trial details
Recruitment status not started as of the registry date. The intervention is a device described in the study fields. The record confirms the link to the study page.
What is the device and regulatory context?
The device is identified as a Coronary Artery Drug Coated Balloon Dilatation Catheter. The source text does not include results or performance claims. This entry shows a registry style submission for a device trial with human participants to evaluate safety signals. The sponsor is DK Medical Technology (Suzhou) Co., Ltd.
What does the protocol cover?
The text specifies conditions and interventions as described above. It does not include trial endpoints, sample size, or statistical analysis details. The status remains not yet recruiting and is posted on ClinicalTrials.gov with the provided identifier.
What are the implications for patients and developers?
For patients, the status indicates potential access to a new coronary artery device in the future pending regulatory review and trial outcomes. For developers and the regulatory team, the entry demonstrates ongoing device level investigation with a not yet recruiting status and sponsor disclosure. No efficacy or safety results are provided in the registry excerpt.
FAQ
- 1. What device is being studied?
The protocol lists a Coronary Artery Drug Coated Balloon Dilatation Catheter as the intervention. - 2. Who sponsors the trial?
DK Medical Technology (Suzhou) Co., Ltd. is listed as the sponsor. - 3. Where is the trial registered?
ClinicalTrials.gov entry NCT07415902 is cited. - 4. What is the recruitment status?
Not yet recruiting at the time of the registry. - 5. Where can I find more information?
The study page link provided in the registry is the primary source.
Conclusion
Not yet recruiting status signals early stage evaluation. Stakeholders should monitor the ClinicalTrials.gov page for updates and ensure regulatory alignment with the MDR framework as the study progresses.
Disclaimer
Professional use only. This summary is not legal advice. It reflects the source text and publicly available registry data.
Announcement information
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07415902?term=medical+device