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Femoropopliteal DiseaseDASBADNCT07136883

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

A study testing POBA and Scoring Balloon in people with Femoropopliteal Disease and Drug Coated Balloon, run by Marc Sirvent at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
POBA and Scoring Balloon
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
83 participants
Where
1 siteSpain
Study dates
25 Sep 2020to 31 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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).
  • Other comorbidities that, in the opinion of the investigator, would prevent the subject from receiving this treatment and/or from complying with the follow-up required by this trial.
  • Known hypersensitivity or allergy to contrast agents that cannot be managed medically.
  • Known hypersensitivity or allergy to heparin, aspirin, paclitaxel, clopidogrel, or other antiplatelet/anticoagulant therapies.
  • Contraindication to the use of dual antiplatelet therapy.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Fundació Privada Hospital Asil de Granollers

    Granollers, Barcelona, 08402

Other trials in Spain

About this study

Official title: Drug-coated Balloon Angioplasty Outcomes After Plain or Scoring Balloon for Vessel Preparation in Patients With Femoropopliteal Arterial Disease. The DASBAD Study: A Prospective Randomized Controlled Trial.

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:

Read more
  1. Does using a scoring balloon reduce the need for a bailout stent during the procedure?
  2. Does a scoring balloon help keep the artery open longer?
  3. Is the cost of the scoring balloon procedure similar to the cost of the POBA procedure?

Participants will:

  • 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
Read the detailed description

A prospective, single-center clinical trial has been designed with two parallel intervention groups of consecutive CLI patients (Rutherford classification 4-5) with lesions in the F-P segment. It is a single-blind study, where the patient is unaware of their group allocation, but the operator knows the group of each patient.

Patients will be randomly assigned to undergo either conventional balloon angioplasty or AngioSculpt™ scoring balloon angioplasty prior to drug-coated balloon (Luminor™) treatment.

PROCEDURE DESCRIPTION

Antithrombotic Therapy (Pre-, Intra-, and Post-Procedure):

All patients will be on at least single antiplatelet therapy prior to the procedure, receiving either aspirin (100-300 mg/day) or clopidogrel (75 mg/day).

During the procedure, an intravenous bolus of heparin (1 mg/kg body weight) will be administered.

The postprocedural antithrombotic regimen includes:

Clopidogrel: 75 mg/day starting immediately after the index procedure. Aspirin: 100-300 mg/day starting immediately after the index procedure. Dual antiplatelet therapy (DAPT) must be maintained for a minimum of 1 year following the index procedure.

Discontinuation is only permitted if a subsequent procedure requires temporary interruption of one or both antiplatelet agents. In such cases, therapy should be resumed as soon as clinically feasible.

Treatment of Non-Target Lesions:

All significant inflow-limiting lesions (≥50% stenosis) in the study limb must be treated successfully (i.e., ≤30% residual stenosis) prior to initiation of the study index procedure. Treatment should follow the institution's standard of care and reflect current evidence regarding the efficacy of available therapies.

Procedure Sequence of the Target Lesion Treatment:

  1. Pre-dilatation of the lesion Pre-dilatation is mandatory and must be performed using either a standard balloon or an AngioSculpt™ scoring balloon, according to the patient's allocation group.
  2. Balloon diameter must match the reference vessel diameter (RVD) in a 1:1 ratio.
  3. The balloon must cover the entire length of the lesion.
  4. A minimum inflation time of 180 seconds is mandatory.
  5. Angiographic imaging must be recorded both before and after pre-dilatation to document the result.
  6. Dilatation with Luminor™ drug-coated balloon (DCB) Following pre-dilatation, lesion treatment is completed using the Luminor™ balloon catheter.
  7. A 1:1 RVD to balloon diameter ratio must be used.
  8. The DCB must cover the entire lesion length and extend at least 1 cm proximally and distally beyond the area previously treated with plain balloon angioplasty.
  9. A minimum inflation time of 180 seconds is mandatory.
  10. Angiographic imaging must be recorded post-dilatation to assess the result.

Definition of Procedural Success.

Treatment of the target lesion is considered successful when the final angiographic result meets both of the following criteria:

  1. Residual stenosis is <30% by visual estimation, or there is no flow-limiting dissection;
  2. Findings are confirmed in two angiographic projections with a minimum angulation difference of 20°.

If the angiographic result is inconclusive, intraoperative duplex ultrasonography must be performed to evaluate lesion patency and result adequacy.

Bail-Out Stenting Criteria:

In cases where the result after DCB angioplasty is inadequate, bail-out stenting is permitted using the following guidelines:

  1. Spot stenting should be performed whenever possible.
  2. The use of covered stents or drug-coated/drug-eluting stents is not allowed under the study protocol.
Being tested
POBA, Scoring Balloon
Keywords
Periferal Artery Disease, Femoropopliteal Disease, Drug coated balloon, Vessel preparation, randomized controlled trial, Critical Limb Ischemia, scoring balloons, Bailout stent
Medical subject headings
Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • POBADevice

    Also called Control group, Group 1

    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.

  • Scoring BalloonDevice

    Also called Group 2, Treatment group, Intervention group

    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.

Study groups in NCT07136883
Study groupRoleWhat they receive
POBAActive comparatorVessel preparation using plain old balloon (POBA) prior to using drug coated balloon (Luminor™; Manufacturer: iVascular, S.L.U., Barcelona, Spain) as definitve treatment.
Receives: Device: POBA
Scoring balloonActive comparatorVessel 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.
Receives: Device: Scoring Balloon

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: At index procedure

  2. 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)

    Measured: 12 months

Secondary outcomes (7)

  1. 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)

    Measured: 1, 6, 18 and 24 months

  2. Clinically Driven Target Lesion Revascularization (CD-TLR)

    Defined as any reintervention due to clinical deterioration*, to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge respectively.

    *defined as a worsening of the patient's quality of life, reflected by the EQ5D-questionnaire, worsening of the Rutherford category with minimal 1 class or worsening of wound healing.

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

  3. 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.

    Major Adverse Clinical Events (MACE)

    • Death
    • Myocardial infarction
    • Stroke
    • Bleeding complication requiring transfusion

    Freedom from major adverse limb events (MALE) defined as absence of above-the-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, thrombectomy/thrombolysis, endovascular reintervention…).

    Measured: 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.

  4. Technical success

    Technical success is defined as successful use of a device or technique to re-establish vessel patency with a residual stenosis of <30% by visual estimation and residual stenosis less than 50% by duplex imaging

    Measured: During the procedure

  5. Procedural success

    Procedural success is defined as technical success and completion of the procedure without complications. This represents successful treatment of the vessels (technical success) in the absence of vessel rupture, distal embolization, thrombosis, access complications, and major adverse cardiovascular events.

    Measured: Occurring <24 hours and <1 month of the procedure

  6. Wound healing time

    Wound healing time is defined as the number of days required for the wound to achieve complete healing following the index procedure.

    Measured: The observation period extends from the date of randomization until the earliest of the following: wound healing, death from any cause, or study completion.

  7. Procedural cost

    Procedural cost is defined as the total price in euros of all balloons and stents used

    Measured: Index procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2025
  2. Study start25 Sep 2020
  3. Primary completion31 Oct 2022
  4. Study completion31 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
83 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07136883
Sponsor's protocol ID
AC-20-080-HGT-CEIMPS
Acronym
DASBAD
Status last verified
Aug 2025
First submitted
8 Aug 2025
Last updated
29 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data collected within the DASBAD study will be made available to researchers upon reasonable request. Access to the data is controlled to ensure the protection of participant privacy and compliance with applicable data protection laws and regulations. Data will be shared upon revision and approval based on scientific merit by the DASBAD management group (which includes a qualified statistician) of a detailed proposal for their use. The data required for the approved, specified purposes and the trial protocol will be provided after the completion of a data-sharing agreement that will be set up by the principal investigator and his team. All data provided will be anonymized to respect the privacy of patients who have participated in the trial. Estimated timeframe for response will be within 30 days. Requests for data should be addressed to the corresponding author (M.S.G.; msirvent@fphag.org).

Publications

  • 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.

    PubMed 34217209

  • 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.

    PubMed 36332764

  • 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.

    PubMed 31724469

  • 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.

    PubMed 32249658

  • 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.

    PubMed 35864209

  • 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.

    PubMed 22192663

  • Sirvent M, Riera C, Gil M, Marti-Mestre X, Artigas V, Bellmunt-Montoya S. Drug Coated Balloon Angioplasty after Plain or Scoring Balloon for Vessel Preparation for Femoropopliteal Arterial Disease (DASBAD): A Randomised Controlled Trial. Eur J Vasc Endovasc Surg. 2026 Jun 3:S1078-5884(26)00513-7. doi: 10.1016/j.ejvs.2026.05.034. Online ahead of print.

    PubMed 42242352

Questions about this trial

What is this clinical trial studying?

A study testing POBA and Scoring Balloon in people with Femoropopliteal Disease and Drug Coated Balloon, run by Marc Sirvent at 1 site in Spain.

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 8 inclusion and 19 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: finished, as of the sponsor's last update on 29 Aug 2025. 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 Spain. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bailout stenting (time frame: At index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07136883, which also lists 7 linked publications.

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 29 Aug 2025; AzTrials last refreshed its copy on 1 Nov 2026.

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