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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-25

Study Completion Date

2022-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Randomized Comparison of DCB for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease

NCT02648334

Angioplasty, Balloon Catheterization, Peripheral Popliteal Artery +1 more

COMPLETED NA

Sirolimus Coated Balloon Versus Standard Balloon for SFA and Popliteal Artery Disease

NCT04511234

Peripheral Artery Disease Atherosclerosis Arterial Disease

RECRUITING NA

Study Comparing Legflow Versus Bare Balloon Angioplasty for Treatment of Atherosclerotic Disease

NCT02710656

Atherosclerosis

COMPLETED NA

DEB ( Drug Eluting Balloon) in Crural Arteries and Critical Limb Ischemia

NCT02750605

Peripheral Vascular Diseases

COMPLETED NA

FeMoropopliteal AngioSculpt™ SCoring BallOon CaTheter Study

NCT00619788

Peripheral Arterial Occlusive Disease

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

POBA

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

Group Type ACTIVE_COMPARATOR

POBA

Intervention Type 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.

Scoring balloon

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.

Group Type ACTIVE_COMPARATOR

Scoring Balloon

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

POBA

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.

Intervention Type DEVICE

Scoring Balloon

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Control group Group 1 Group 2 Treatment group Intervention group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No