Status:
COMPLETED
DCB Outcomes After Plain or Scoring Balloon for Vessel Preparation in Patients With Femoropopliteal Arterial Disease
Lead Sponsor:
Marc Sirvent
Conditions:
Femoropopliteal Disease
Drug Coated Balloon
Eligibility:
All Genders
18+ years
Phase:
NA
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 (calle...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 25 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2022
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT07136883
Start Date
September 25 2020
End Date
October 31 2022
Last Update
August 29 2025
Active Locations (1)
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1
Fundació Privada Hospital Asil de Granollers
Granollers, Barcelona, Spain, 08402