A new prospective, multicenter cohort study aims to delve deeper into the treatment options for femoropopliteal in-stent restenosis (ISR). Sponsored by a consortium of leading vascular surgery departments across multiple Chinese hospitals and universities, this trial will compare the effectiveness of drug-coated balloons against drug-eluting stents for ISR treatment. The study is not yet recruiting patients as of December 2025.
What changed?
This study, registered under NCT07277218 on ClinicalTrials.gov, is a focused effort to address the challenges of ISR in the femoropopliteal arteries. Drug-coated balloons and drug-eluting stents are widely used interventions, but their comparative long-term effectiveness in this context remains unclear. By December 2025, the trial marks a pivotal step forward in clinical research concerning vascular device strategies.
Study details
Background
Femoropopliteal ISR is a recurrent issue in vascular surgery, often requiring repeat intervention. This trial, initiated by Chunshui He and a cohort of prominent vascular departments, will rigorously assess the efficacy, safety, and durability of the two therapeutic devices. The study brings together institutions across China, including Hangzhou First People’s Hospital and Huashan Hospital affiliated with Fudan University.
Methods
The study design incorporates real-world data from multiple clinical centers, building a robust evidence base. Patients diagnosed with femoropopliteal ISR will undergo randomized treatment with either drug-coated balloons or drug-eluting stents. Post-procedure outcomes such as patency rate, re-intervention rates, and safety metrics will be monitored over time.
Implications for practitioners
Clinical teams and regulatory professionals should closely follow this study as it unfolds. The findings may influence treatment guidelines, medical training programs, and even device approval pathways. Companies manufacturing similar devices may find this study a benchmark for regulatory submissions.
FAQ
1. What is femoropopliteal in-stent restenosis (ISR)?
ISR refers to the re-narrowing of an artery within a previously placed stent, typically because of scar tissue or plaque build-up.
2. Why compare drug-coated balloons to drug-eluting stents?
Both devices aim to prevent arterial re-narrowing, but their mechanisms differ. This study hopes to clarify which offers better long-term outcomes.
3. Who sponsors the study?
The trial is sponsored by prominent vascular surgery departments in leading Chinese hospitals and universities.
Conclusion
This upcoming study holds promise for advancing device-based solutions for ISR treatment. Clinical, regulatory, and manufacturing teams should keep an eye out for updates as the research progresses through 2025 and beyond.
Disclaimer
The information in this article is intended for professionals. It does not constitute medical or legal advice. Always consult official sources for definitive guidance.
Official announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07277218?term=medical+device