DCB Outcomes After Plain or Scoring Balloon for Vessel Preparation in Patients With Femoropopliteal Arterial Disease

NCT07136883 | Completed

• 1 other identifier: AC-20-080-HGT-CEIMPS
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if using a scoring balloon to prepare the femoropopliteal (FP) segment before drug-coated balloon treatment works better than using a regular balloon (called plain old balloon angioplasty, or POBA). This study includes only people with critical limb ischemia (CLI). The main questions it aims to answer are:

• Receive either a scoring balloon or POBA to prepare the femoropopliteal segment
• Then be treated with a drug-coated balloon in the same segment
• Be monitored during the procedure to see if a bailout stent is needed
• Have follow-up visits to see if the artery remains open

Conditions

Femoropopliteal Disease; Drug Coated Balloon; Critical Limb Ischemia (CLI); Peripheral Arterial Disease

Keywords

Periferal Artery Disease; Femoropopliteal Disease; Drug coated balloon; Vessel preparation; randomized controlled trial; Critical Limb Ischemia; scoring balloons; Bailout stent

Outcome Measures

Primary Outcomes (2)

• Bailout stenting

  The need for bailout stenting during the index procedure, defined as implantation due to residual stenosis \>30% or flow-limiting dissection (type C according to the Kobayashi classification)

  At index procedure

• Primary patency

  Defined by duplex ultrasound as absence of ≥50% restenosis (velocity peak ratio \<2.5) and no clinically driven target lesion revascularisation (CD-TLR)

  12 months

Secondary Outcomes (7)

• Primary patency

  1, 6, 18 and 24 months

• Clinically Driven Target Lesion Revascularization (CD-TLR)

  At 1 month, every 6 months up to 2 years post-procedure

• Freedom from device and procedure-related death and freedom from Major Adverse Events (MAE), including Major Adverse Clinical Events (MACE) and Major Adverse Limb Events(MALE)

  1- Freedom from device and procedure-related death through 30 days post-procedure 2- Freedom from MAE (MACE and MALE) at 1 month, every 6 months up to 2 years post-procedure.

• Technical success

  During the procedure

• Procedural success

  Occurring <24 hours and <1 month of the procedure

Study Arms (2)

POBA

ACTIVE COMPARATOR

Vessel preparation using plain old balloon (POBA) prior to using drug coated balloon (Luminor™; Manufacturer: iVascular, S.L.U., Barcelona, Spain) as definitve treatment.

Device: POBA

Scoring balloon

ACTIVE COMPARATOR

Vessel preparation using scoring balloon (AngioSculpt™; Manufacturer: Spectranetics Corporation, Fremont, California, USA) prior to using drug coated balloon (Luminor™; Manufacturer: iVascular, S.L.U., Barcelona, Spain) as definitve treatment.

Device: Scoring Balloon

Interventions

POBA DEVICE

The intervention consists of preparing the artery with a traditional/regular angioplasty balloon before using the DCB (Luminor™; Manufacturer: iVascular, S.L.U., Barcelona, Spain) as the definitive treatment.

Also known as: Control group, Group 1

POBA

Scoring Balloon DEVICE

The intervention consists of preparing the artery with a scoring balloon (Angiosculpt™; Manufacturer: Spectranetics Corporation, Fremont, California, USA) before using the DCB (Luminor™; Manufacturer: iVascular, S.L.U., Barcelona, Spain) as the definitive treatment.

Also known as: Group 2, Treatment group, Intervention group

Scoring balloon

Eligibility Criteria

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

You may qualify if:

• Male or non-pregnant female subjects aged ≥18 years at the time of informed consent. Women of childbearing potential must have a negative pregnancy test within 7 days prior to the procedure and must agree to use a reliable method of contraception during their participation in the study. This requirement does not apply in cases of sterility, infertility, or menopause for at least 12 months.
• Rutherford category 4-5.
• Life expectancy \>1 year as assessed by the investigator, based on the patient's medical history.
• Atherosclerotic lesions in the femoropopliteal segment, including in-stent restenosis.
• The subject has been informed, understands the nature of the trial, and has signed the informed consent form to participate in the study. If the subject is capable of understanding and providing informed consent but is physically unable to sign the consent form, an impartial witness may sign on their behalf.
• The patient is willing to comply with all required follow-up visits.
• Presence of at least one patent infragenicular artery (with \<50% stenosis) at the end of the procedure.
• Target vessel diameter ≤8 mm.

You may not qualify if:

• Pregnant women or women planning to become pregnant during the course of the study.
• Participation in another investigational drug eluting technology study.
• Inability to successfully cross the target lesion with a guidewire (successful crossing is defined as the guidewire tip passing through the lesion without perforation and remaining within the true arterial lumen).
• Inadequate treatment of a proximal lesion (defined as \>30% residual stenosis).
• Severe calcification of the target vessel, defined as 270-360 degrees of circumferential calcification (Fanelli grade 4 classification).
• Presence of thrombus in the target vessel.
• Stenosis at the anastomosis site of a bypass.
• Use of atherectomy, thrombectomy, laser, or any similar device in the target lesion/vessel.
• Prior or planned above-ankle amputation of the target limb (this does not apply to transmetatarsal, digital amputations, or ulcer debridement).
• Known coagulopathy, hypercoagulable state, bleeding diathesis, platelet count \<80,000/μL or \>700,000/μL, or any other hematological disorder.
• History of gastrointestinal bleeding requiring transfusion within the 3 months prior to the study procedure.
• Any subject for whom the use of antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated.
• Acute coronary syndrome within 30 days prior to the index procedure.
• History of stroke or transient ischemic attack (TIA) within 90 days prior to the index procedure.
• Known hypersensitivity or contraindication to nickel-titanium alloy (Nitinol).

Sponsors & Collaborators

• Marc Sirvent: lead

Study Sites (1)

Fundació Privada Hospital Asil de Granollers

Granollers, Barcelona, 08402, Spain

Location

Related Publications (6)

• Yu X, Zhang X, Lai Z, Shao J, Zeng R, Ye W, Chen Y, Zhang B, Ma B, Cao W, Liu X, Yuan J, Zheng Y, Yang M, Ye Z, Liu B. One-year outcomes of drug-coated balloon treatment for long femoropopliteal lesions: a multicentre cohort and real-world study. BMC Cardiovasc Disord. 2021 Jul 3;21(1):326. doi: 10.1186/s12872-021-02127-x.

  PMID: 34217209 BACKGROUND

• Shishehbor MH, Scheinert D, Jain A, Brodmann M, Tepe G, Ando K, Krishnan P, Iida O, Laird JR, Schneider PA, Rocha-Singh KJ, Zeller T. Comparison of Drug-Coated Balloons vs Bare-Metal Stents in Patients With Femoropopliteal Arterial Disease. J Am Coll Cardiol. 2023 Jan 24;81(3):237-249. doi: 10.1016/j.jacc.2022.10.016. Epub 2022 Nov 1.

  PMID: 36332764 BACKGROUND

• Karashima E, Yoda S, Yasuda S, Kajiyama S, Ito H, Kaneko T. Usefulness of the "Non-Slip Element" Percutaneous Transluminal Angioplasty Balloon in the Treatment of Femoropopliteal Arterial Lesions. J Endovasc Ther. 2020 Feb;27(1):102-108. doi: 10.1177/1526602819887954. Epub 2019 Nov 14.

  PMID: 31724469 BACKGROUND

• Horie K, Tanaka A, Taguri M, Inoue N. Impact of Scoring Balloons on Percutaneous Transluminal Angioplasty Outcomes in Femoropopliteal Lesions. J Endovasc Ther. 2020 Jun;27(3):481-491. doi: 10.1177/1526602820914618. Epub 2020 Apr 6.

  PMID: 32249658 BACKGROUND

• Brodmann M, Lansink W, Guetl K, Micari A, Menk J, Zeller T. Long-Term Outcomes of the 150 mm Drug-Coated Balloon Cohort from the IN.PACT Global Study. Cardiovasc Intervent Radiol. 2022 Sep;45(9):1276-1287. doi: 10.1007/s00270-022-03214-y. Epub 2022 Jul 21.

  PMID: 35864209 BACKGROUND

• Tosaka A, Soga Y, Iida O, Ishihara T, Hirano K, Suzuki K, Yokoi H, Nanto S, Nobuyoshi M. Classification and clinical impact of restenosis after femoropopliteal stenting. J Am Coll Cardiol. 2012 Jan 3;59(1):16-23. doi: 10.1016/j.jacc.2011.09.036.

  PMID: 22192663 BACKGROUND

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Marc Sirvent, PhD

  Fundació Privada Hospital Asil de Granollers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Angiology and Vascular Surgery Department, Principal investigator

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 22, 2025
• Study Start: September 25, 2020
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)