Femoropopliteal Artery OcclusionEarly Phase 1DCB-Debulk-COMNCT07406308
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 Early Phase 1 study testing paclitaxel-coated balloon angioplasty and paclitaxel-coated balloon angioplasty with debulking procedures in people with Femoropopliteal Artery Occlusion, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Femoropopliteal Artery Occlusion
- What is being tested?
- paclitaxel-coated balloon angioplasty and paclitaxel-coated balloon angioplasty with debulking procedures
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 408 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2026to 30 May 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Peking Union Medical College Hospital
Beijing, 100730
Peking Union Medical College Hospital, 86-1069152501, nileng@163.com
About this study
Official title: 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.
Read the 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
- Being tested
- paclitaxel-coated balloon angioplasty, paclitaxel-coated balloon angioplasty with debulking procedures
- Keywords
- Femoropopliteal Artery Occlusion, Drug-Coated Balloon, debulking procedures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel-coated balloon angioplastyDevice
No debulking procedures were taken
paclitaxel-coated balloon angioplasty with debulking proceduresDevice
The patient underwent DCB treatment along with debulking procedures (such as laser or plaque rotational atherectomy, etc.).
| Study group | Role | What they receive |
|---|---|---|
| DCB | Active comparator | Participants in this group will be received drug-coated balloon angioplasty Receives: Device: paclitaxel-coated balloon angioplasty |
| DCB+DP | Experimental | Participants in this group will be received drug-coated balloon angioplasty with debulking procedures. Receives: Device: paclitaxel-coated balloon angioplasty with debulking procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-year primary patency rate
Measured: 1 year
Secondary outcomes (1)
free from clinical-driven target lesion revascularization
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start20 Apr 2026 (estimated)
- Primary completion20 Mar 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoropopliteal Artery OcclusionStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, non-randomized, controlled cohort study. 1. Eligible patients with chronic femoropopliteal artery occlusions will be assigned to one of the two treatment groups based on a combination of clinical assessment, anatomical factors, and patient preference: (1) the Combination Therapy Group (paclitaxel-coated balloon angioplasty with adjunctive atherectomy/debulking), or (2) the DCB-Alone Group (paclitaxel-coated balloon angioplasty alone). 2. Treatment allocation is not randomized. Patients in both groups will be prospectively followed and their outcomes compared to assess the relative efficacy and safety of the two treatment strategies.
- Masking
- None (open label)
- Enrolment
- 408 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07406308
- Sponsor's protocol ID
- PCB_ATH
- Acronym
- DCB-Debulk-COM
- Status last verified
- Jan 2026
- First submitted
- 5 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07406308
- Acronym / sponsor ID
- DCB-Debulk-COM / PCB_ATH
- Conditions
- Femoropopliteal Artery Occlusion
- Keywords
- Femoropopliteal Artery Occlusion, Drug-Coated Balloon, debulking procedures
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 408 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- 20 Mar 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, non-randomized, controlled cohort study. 1. Eligible patients with chronic femoropopliteal artery occlusions will be assigned to one of the two treatment groups based on a combination of clinical assessment, anatomical factors, and patient preference: (1) the Combination Therapy Group (paclitaxel-coated balloon angioplasty with adjunctive atherectomy/debulking), or (2) the DCB-Alone Group (paclitaxel-coated balloon angioplasty alone). 2. Treatment allocation is not randomized. Patients in both groups will be prospectively followed and their outcomes compared to assess the relative efficacy and safety of the two treatment strategies.
| Arm | Type | Receives |
|---|---|---|
| DCB | Active comparator | Device: paclitaxel-coated balloon angioplastyParticipants in this group will be received drug-coated balloon angioplasty |
| DCB+DP | Experimental | Device: paclitaxel-coated balloon angioplasty with debulking proceduresParticipants in this group will be received drug-coated balloon angioplasty with debulking procedures. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paclitaxel-coated balloon angioplastyNo debulking procedures were taken | Device | DCB |
| paclitaxel-coated balloon angioplasty with debulking proceduresThe patient underwent DCB treatment along with debulking procedures (such as laser or plaque rotational atherectomy, etc.). | Device | DCB+DP |
Primary outcome
1-year primary patency rate
Time frame: 1 year
1 secondary outcome
free from clinical-driven target lesion revascularization
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing paclitaxel-coated balloon angioplasty and paclitaxel-coated balloon angioplasty with debulking procedures in people with Femoropopliteal Artery Occlusion, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leng Ni, MD (86-1069152501, nileng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1-year primary patency rate (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.