Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis: A Prospective, Multicenter, Cohort Study

Summary

Brief Summary: Defier Study What is this study about? Femoropopliteal artery disease (a type of peripheral arterial disease) often requires stenting to restore blood flow to the legs. However, a common challenge after stenting is in-stent restenosis (ISR)-the treated blood vessel narrows again over time. Two advanced treatments for ISR are available: drug-coated balloons (DCBs) and drug-eluting stents (DESs). Both deliver medication to prevent vessel narrowing, but there is limited direct evidence comparing how well they work for ISR in the femoropopliteal artery (the main artery from the thigh to the knee).

This study (called the "Defier Study") aims to fill this gap by directly comparing the safety and effectiveness of DCBs and DESs for treating femoropopliteal ISR. The results will help doctors choose the best treatment for patients with this condition.

Who can take part in the study?

Eligible patients must:

Be 18 years or older and able to provide informed consent. Have symptoms of reduced blood flow to the legs (Rutherford class 2-5, e.g., pain when walking, rest pain, or skin changes).

Have a narrowed (≥50%) or blocked femoropopliteal stent (implanted more than 30 days earlier), with the affected area no longer than 30 cm.

Have at least one open blood vessel below the knee (to ensure blood flow after treatment).

Agree to attend follow-up visits for 2 years.

Patients will be excluded if:

They are pregnant/lactating, have severe vessel calcification that prevents treatment, or have acute limb ischemia/thrombosis.

They have a history of stroke in the past 60 days, contraindications to blood-thinning medications, or a life expectancy of less than 2 years.

How is the study conducted? This is a prospective, multicenter cohort study (observing patients over time) conducted at multiple university-affiliated hospitals in China. A total of 578 eligible patients will be enrolled over approximately 2 years.

Treatment assignment:

Doctors will choose either DCB or DES based on clinical judgment and real-world practice:

DCB group: The narrowed area is first expanded with a standard balloon, then treated with a paclitaxel-coated balloon (to deliver medication to the vessel wall). A bare-metal stent may be used if needed (e.g., if the vessel tears or remains too narrow after DCB treatment).

DES group: After initial balloon expansion, a paclitaxel-eluting stent (a stent that slowly releases medication) is implanted to cover the entire narrowed area.

Follow-up:

Patients will be checked at 1, 3, 6, 12, and 24 months after treatment. Tests will include ultrasound (to check vessel patency), ankle-brachial index (ABI, a measure of blood flow), and assessments of symptoms and adverse events.

What are the study's key goals?

Primary goal (main outcome):

To compare the rate of clinically driven target lesion revascularization (CD-TLR) at 24 months. CD-TLR means needing repeat procedures (e.g., balloon angioplasty or stenting) on the treated area because of worsening symptoms or reduced blood flow.

Secondary goals:

Rates of major adverse limb events (MALE, including major leg amputation).

Vessel patency (whether the treated area stays open):

Primary patency: The vessel remains open without repeat intervention. Secondary patency: The vessel stays open after additional interventions if needed.

Improvement in symptoms and blood flow (measured by ABI and Rutherford class). Stent fracture rate (for DES patients) and safety outcomes (e.g., 30-day death, bleeding, heart attack, or organ function decline).

Is the study safe and regulated? The study has been approved by the Medical Ethics Committee of the Affiliated Hospital of Chengdu University of Traditional Chinese Medicine (Approval No. 2020KL-078) and follows the Declaration of Helsinki (international ethical standards for medical research).

It is registered on ClinicalTrials.gov (NCT04675632) and results will be published in a peer-reviewed medical journal.

Why is this study important? By directly comparing DCBs and DESs-two of the most advanced treatments for femoropopliteal ISR-this study will provide high-quality evidence to help doctors make better treatment decisions. For patients, this means more personalized, effective care that reduces the need for repeat procedures and improves quality of life.

For healthcare providers, the results will clarify which treatment works best for different patients (e.g., those with complex lesions) and optimize endovascular strategies for ISR.

Conditions

• Femoropopliteal In-Stent Restenosis (ISR)

Interventions

PROCEDURE

Drug-coated Balloons versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis

DCB Cohort: Lesions treated primarily with a paclitaxel-coated balloon, with provisional bare-metal stenting allowed for suboptimal results. DES Cohort: Lesions treated primarily with a paclitaxel-eluting stent.

Sponsors & Collaborators

• Department of Vascular Surgery, The First Affiliated Hospital of Medicine College of Zhejiang University, Hangzhou, China.

  collaborator UNKNOWN

• Department of Vascular Surgery, Liyuan Hospital Affiliated Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.

  collaborator UNKNOWN

• Department of Vascular Surgery, Qingdao Haici Hospital Affiliated to Qingdao University, Qingdao, China.

  collaborator UNKNOWN

• Department of Vascular Surgery, School of Medicine, Affiliated Hangzhou First People's Hospital, Zhejiang University, Hangzhou, China.

  collaborator UNKNOWN

• Department of Vascular Surgery, The Second Affiliated Hospital of Soochow University, Suzhou, China.

  collaborator UNKNOWN

• Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai, China.

  collaborator UNKNOWN

• Department of Vascular Surgery, Huashan Hospital, Fudan University, Shanghai, China.

  collaborator UNKNOWN

• Department of Cardiovascular Surgery, Xiamen Cardiovascular Hospital of Xiamen University, School of Medicine, Xiamen University, Xiamen, China.

  collaborator UNKNOWN

• Department of Vascular Surgery, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.

  collaborator UNKNOWN

• Biomedical Informatics and Statistics Center, School of Public Health.Fudan University, Shanghai, China.

  collaborator UNKNOWN

• Department of Vascular Surgery, Xuanwu Hospital Capital MedicalUniversity, Beijing, China.

  collaborator UNKNOWN

• Chunshui He

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2028-01-01

Completion

2028-01-01