NCT07406308

A Comparative Analysis of Mid- to Long-Term Outcomes: Paclitaxel-Coated Balloon With Debulking Versus Paclitaxel-Coated Balloon Alone in the Treatment of Chronic Femoropopliteal Artery Occlusions

A Comparative Analysis of Mid- to Long-Term Outcomes of Paclitaxel-Coated Balloon Angioplasty With Adjunctive Debulking Versus Paclitaxel-Coated Balloon Angioplasty Alone for the Treatment of Chronic Femoropopliteal Artery Occlusions

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 408 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study aims to compare mid-to long-term outcomes of paclitaxel-coated balloon angioplasty with adjunctive debulking versus paclitaxel-coated balloon angioplasty alone for the treatment of chronic femoropopliteal artery diseases.

Detailed description

Chronic femoropopliteal artery occlusion, particularly in long lesions, remains a significant challenge in endovascular treatment of lower extremity arterial disease due to its high occlusion burden and severe vascular calcification. In recent years, with the continuous advancement of endovascular techniques and devices, especially the emergence of the "leave nothing behind" concept, Drug-Coated Balloon (DCB) angioplasty has become a mainstream approach for treating femoropopliteal occlusions. While DCB offers excellent long-term patency and preserves future treatment options, adjunctive debulking procedures-a category of techniques that physically remove or ablate plaque prior to DCB dilation to achieve a larger, smoother lumen-have gained attention. These techniques primarily include atherectomy, laser ablation, and directional atherectomy. They can address more complex lesions and offer potential benefits such as enhanced drug absorption, reduced elastic recoil, and decreased need for bailout stenting. However, they also carry risks, including distal embolism and perforation. Consequently, the comparative efficacy between DCB alone and DCB combined with debulking measures remains uncertain, and the choice of treatment strategy still largely depends on operator experience. Therefore, an in-depth investigation is necessary to compare the efficacy and safety of these two approaches to inform and guide optimal clinical decision-making.

Conditions

• Femoropopliteal Artery Occlusion

Interventions

Type	Name	Description
DEVICE	paclitaxel-coated balloon angioplasty	No debulking procedures were taken
DEVICE	paclitaxel-coated balloon angioplasty with debulking procedures	The patient underwent DCB treatment along with debulking procedures (such as laser or plaque rotational atherectomy, etc.).

Timeline

• Start date: 2026-04-20
• Primary completion: 2028-03-20
• Completion: 2028-05-30
• First posted: 2026-02-12
• Last updated: 2026-02-12

Locations

1 site across 1 country: China