NCT05620095

Durg Coated Balloon Angioplasty in Infrapopliteal Lesions

Multicenter Registry for pAclitaxel- Coated Balloon angioplasTy in Infrapopliteal Arterial Lesions (the ACT Study)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter observational study designed to evaluate the the effectiveness and safety of drug-coated balloon (DCB) angioplasty for below the knee arterial lesions in patients critical with Limb Threatening Ischemia (CLTI).

Detailed description

Patients with critical limb ischemia (Rutherford category 4-6) and significant infrapopliteal lesions appropriate for angioplasty will be enrolled in this study. Subjects will be treated with the AcoArt drug coated balloon, then follow-up will be conducted at 1, 3, 6, 12 months after index procedure. Data on wound, ischemia, foot infection (WIfI) calcifications, clinical improvements, wound healing, freedom form target- lesion revascularization, patency of the target lesion and major adverse events will be collected.

Conditions

• Arteriosclerosis
• Peripheral Artery Disease
• Chronic Limb Threatening Ischemia

Interventions

Type	Name	Description
DEVICE	drug-coated balloon	To evaluate the effectiveness and safety of drug-coated balloon angioplasty for infrapopliteal artery lesions in patients with CLTI.

Timeline

• Start date: 2020-12-01
• Primary completion: 2025-11-01
• Completion: 2026-11-01
• First posted: 2022-11-17
• Last updated: 2026-03-25

Locations

10 sites across 1 country: China