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:

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

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.

   1. Balloon diameter must match the reference vessel diameter (RVD) in a 1:1 ratio.
   2. The balloon must cover the entire length of the lesion.
   3. A minimum inflation time of 180 seconds is mandatory.
   4. Angiographic imaging must be recorded both before and after pre-dilatation to document the result.

2. Dilatation with Luminor™ drug-coated balloon (DCB) Following pre-dilatation, lesion treatment is completed using the Luminor™ balloon catheter.

   1. A 1:1 RVD to balloon diameter ratio must be used.
   2. 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.
   3. A minimum inflation time of 180 seconds is mandatory.
   4. 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.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).
• 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.

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).