A new clinical trial has been announced to assess two advanced interventions for vascular calcification in patients with calcified coronary lesions. The trial, sponsored by prominent institutions in China, aims to compare the Super High-Pressure Non-Compliant Balloon (RA-SHP) with the Intravascular Lithotripsy System (RA-IVL). As of now, the study is not yet recruiting participants.
What is the study about?
This upcoming clinical trial focuses on managing calcified coronary lesions through two innovative interventions. Vascular calcification, a complex condition, often complicates coronary procedures, requiring devices capable of safely treating calcified plaques.
The study’s primary objective is to evaluate the efficacy and safety of RA-IVL and RA-SHP. Both devices represent different technological approaches to solving the challenge of calcified lesions in coronary arteries.
Examining the devices
Super High-Pressure Non-Compliant Balloon (RA-SHP)
RA-SHP employs high pressure to dilate calcified and narrow coronary arteries. The device’s technology relies on delivering controlled, focused force to remodel stiffened plaques without causing major arterial damage.
Intravascular Lithotripsy System (RA-IVL)
RA-IVL uses sound wave energy to break up calcification. This system is designed for precision, targeting specific areas of calcified blockage while minimizing harm to surrounding tissues. Its gentle approach aims to enhance procedural outcomes for high-risk patients.
Who is behind the study?
The clinical trial is spearheaded by a collaborative effort among experts and institutions in China. Its lead sponsors are Lin Zhao, the China-Japan Friendship Hospital, and Xin Hua Hospital affiliated with the Shanghai Jiao Tong University School of Medicine. These organizations are renowned for their contributions to medical device innovation and clinical research. Such partnerships strengthen the credibility and potential implications of the study’s results.
FAQ
1. When will the trial begin recruiting participants?
The trial is listed as not yet recruiting. Further updates are expected from the sponsoring institutions.
2. Where will the study be conducted?
Specific sites have not been disclosed yet. The study is, however, led by institutions based in China.
3. What is the significance of these devices?
RA-SHP and RA-IVL offer two distinct approaches to treating calcified coronary lesions, which are challenging to address using conventional techniques.
Conclusion
With the rising prevalence of vascular calcification, this trial marks an important step toward identifying safer and more effective medical devices. The comparison of RA-IVL and RA-SHP holds potential to inform clinical practices for treating patients with calcified coronary lesions.
Disclaimer
This article is intended for informational purposes only and should not be considered clinical or legal advice. Professionals should consult relevant regulatory and clinical guidelines when interpreting the content.
Announcement link
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07279987?term=medical+device