Combination Therapy of Atherectomy Plus Drug-coated Balloon Versus Drug-coated Balloon for Complex Femoropopliteal Artery Disease

NCT05307263 | Recruiting DMC

• 1 other identifier: 4-2022-0051
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

• Prospective, multi-center, randomized, controlled comparison study
• A total of 300 subjects with complex femoropopliteal artery disease will be included according to inclusion and exclusion criteria. Complex lesions include long lesions (\>150 mm), calcified lesions (PACSS grade 2-4) and in-stent lesions.
• Patients will be randomized in a 1:1 manner into atherectomy plus drug-coated balloon (DCB) or angiography-guided intervention group. • The randomization will be startified by the participating center and in-stent restenosis lesion. • For the DCB treatment, either IN.PACT (Medtronic) or Ranger (Boston Scientific) DCB will be used. • For the atherectomy, HawkOne (Medtronic), Jetstream (Boston scientific), or Rotarex (Straub Medical) will be used. • The primary endpoint is primary patency at 12 months based on Kaplan-Meier survival analysis. • Ankle-brachial index and Image study follow-up (Duplex US, CT angiography, or catheter angiography) will be performed at 1 year.
• Patients will be followed clinically for 2 years after the procedure.

Conditions

Femoropopliteal Artery Disease

Keywords

Femoropopliteal artery disease; drug-coated balloon; angioplasty; atherectomy

Outcome Measures

Primary Outcomes (1)

• Primary patency

  Primary patency is defined as absence of restenosis \>50% by Duplex ultrasound, CT angiography, or catheter-based angiography

  12 months post treatment

Study Arms (2)

Atherectomy plus DCB

ACTIVE COMPARATOR

Procedure: Combination therapy of atherectomy and DCB

DCB

ACTIVE COMPARATOR

Procedure: DCB alone

Interventions

Combination therapy of atherectomy and DCB PROCEDURE

The target lesion in femoropopliteal artery will be treated with atherectomy folloewd by DCB. The choice of atherectomy devices (HawkOne, Jectstream, or Rotarex)and DCBs (IN.PACT or Ranger) will be left to the operator's decision. In presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of bare nitinol stents is recommended. Implantational of drug-eluting stents is not allowed.

Atherectomy plus DCB

DCB alone PROCEDURE

The target lesion in femoropopliteal artery will be treated with DCB. The choice of DCBs (IN.PACT or Ranger) will be left to the operator's decision. In presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of bare nitinol stents is recommended. Implantational of drug-eluting stents is not allowed.

DCB

Eligibility Criteria

• Age: 19 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19 years or older
• Symptomatic peripheral artery disease:
• Moderate or severe claudication (Rutherford category 2 or 3)
• Critical limb ischemia (Rutherford category 4 or 5)
• Femoropopliteal artery disease (stenosis \> 50%) with one of following complex lesion characteristics: - long lesion (\>150 mm), in-stent restenosis, calcified lesion (PACCS grade 2-4)
• Femoropopliteal artery lesions that operators consider appropriate for treatment with both atherectomy plus drug-coated balloons and drug-coated balloons alone
• Patients with signed informed consent

You may not qualify if:

• Acute critical limb ischemia
• Severe critical limb ischemia (Rutherford category 6)
• Contraindication to any of the following medications: heparin, aspirin, clopidogrel, or contrast agents due to severe hypersensitive reactions
• Age \> 85 years
• Severe hepatic dysfunction (\> 3 times normal reference values)
• Significant thrombocytopenia, anemia, or known bleeding diathesis
• LVEF \< 35% or clinically overt congestive heart failure
• Pregnant women or women with potential childbearing
• Life expectancy \<1 year due to comorbidity
• Previous bypass surgery in the target femoropopliteal artery
• Untreated inflow disease of the ipsilateral pelvic or femoropopliteal arteries (more than 50% stenosis or occlusion)

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

RECRUITING

Central Study Contacts

Young-Guk Ko, MD, PhD

CONTACT

82-2-2228-8460; ygko@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2022
• First Posted: April 1, 2022
• Study Start: September 15, 2022
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 4, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)