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 (DCB-Debulk-COM)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Femoropopliteal Artery Occlusion
• Intervention / Treatment: Device: paclitaxel-coated balloon angioplasty; Device: paclitaxel-coated balloon angioplasty with debulking procedures

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.

• Study Type: Interventional
• Enrollment (Estimated): 408
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Leng Ni, MD; Phone Number: 86-1069152501; Email: nileng@163.com

Study Locations

• China
  • Beijing, China, 100730
    • Peking Union Medical College Hospital
    • Contact: Peking Union Medical College Hospital; Phone Number: 86-1069152501; Email: nileng@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subject age 18-85yrs.
• Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form.
• Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing.
• Rutherford category 2-5.
• Subject has atherosclerotic de novo, non-stented restenotic, or in-stent restenotic/occlusive lesions in the superficial femoral artery (SFA) and/or popliteal artery (P1 segment).
• Patent inflow artery with stenosis <30% by visual estimation (or by core lab assessment if available) and at least 1 infrapopliteal artery to the ankle (<50% diameter stenosis).
• A guidewire has successfully traversed the target treatment segment.

Exclusion Criteria:

• Subject presents with acute arterial embolism or thrombosis requiring thrombectomy or thrombolysis for limb ischemia.
• Subject has arterial occlusion caused by thromboangiitis obliterans (Buerger's disease) or other forms of immune-mediated vasculitis.
• Subject has undergone surgery on the target vessel within the past 3 months, or has experienced repeated failures of endovascular therapy and is deemed unsuitable for further endovascular intervention.
• Subject has an uncontrolled thrombophilia or hypercoagulable state.
• Subject has a severe systemic disease (e.g., malignancy) with a life expectancy of less than 1 year.
• Subject has contraindications or intolerance to antiplatelet/anticoagulant medications, such as aspirin, clopidogrel, or heparin.
• Subject is pregnant or breastfeeding.
• Subject meets one or more of the following conditions: chronic renal insufficiency (SCr ≥ 2.5 mg/dL) or on regular dialysis; cardiovascular or cerebrovascular surgery within the past 1 month; or severe sequelae from a major stroke.
• Subject has a known allergy to nitinol alloy, paclitaxel, or contrast agents.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DCB; Participants in this group will be received drug-coated balloon angioplasty	Device: paclitaxel-coated balloon angioplasty; No debulking procedures were taken
Experimental: DCB+DP; Participants in this group will be received drug-coated balloon angioplasty with debulking procedures.	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.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
1-year primary patency rate	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
free from clinical-driven target lesion revascularization	1 year

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 20, 2026
• Primary Completion (Estimated): March 20, 2028
• Study Completion (Estimated): May 30, 2028

Study Registration Dates

• First Submitted: February 5, 2026
• First Submitted That Met QC Criteria: February 5, 2026
• First Posted (Actual): February 12, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Drug-Coated Balloon; Femoropopliteal Artery Occlusion; debulking procedures
• Other Study ID Numbers: PCB_ATH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No