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

NCT07136883 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2025-08-29

No results posted yet for this study

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:

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

Conditions

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

Interventions

DEVICE

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.

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.

Sponsors & Collaborators

  • Marc Sirvent

    lead OTHER

Principal Investigators

  • Marc Sirvent, PhD · Fundació Privada Hospital Asil de Granollers

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-25
Primary Completion
2022-10-31
Completion
2022-10-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07136883 on ClinicalTrials.gov