Safety and Efficacy of DCB for the Treatment of SFA Ischemic Vascular Disease in Patients With TASC C and D Lesions

June 7, 2017 updated by: Ettore Sansavini Health Science Foundation

Safety and Efficacy of the Drug Coated Balloon (DCB) for the Treatment of the Superficial Femoral Artery (SFA) Ischemic Vascular Disease in Symptomatic Patients Presenting With TASC C and D Lesions: a Pilot Study

The study is aimed at collecting preliminary safety and efficacy data related to the use of Drug Coated Balloon (DCB) technology for the treatment of symptomatic Superficial Femoral Artery (SFA) ischemic vascular disease in patients presenting with long lesions.

The present clinical evaluation is intended as a prospective observational data collection of patient treatment in full accordance with institution standard practice and utilizing an approved (CE marked) DCB currently available on the market.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The present study is designed as a prospective, open label, observational study.

The study will collect information about the medical care patients receive during their planned procedure. No additional testing or procedures will be done.

Patients elected for endovascular revascularization with DCB will be asked their written consent to the use of their personal data.

Revascularization will be performed as per standard procedure of the sites. After discharge all patients will attend clinic visits at 30 days (±14 days), 6 months (±30 days), 12 months (±30 days), 24 and 36 months (±30 days). Angiographic follow-up will be performed in symptomatic patients, as clinically indicated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
      • Bari, Italy, 70124
        • Not yet recruiting
        • Santa Maria Hospital
        • Contact:
          • Giuseppe Roscitano, MD
      • Catania, Italy, 95123
        • Recruiting
        • A.O.U. Policlinico Vittorio Emanuele
        • Contact:
          • Pierfrancesco Veroux, MD, PhD
      • Lecce, Italy, 73100
        • Recruiting
        • Città di Lecce Hospital
        • Contact:
          • Armando Liso, MD
      • Napoli, Italy, 80131
        • Not yet recruiting
        • Policlinico Federico II
        • Contact:
          • Giovanni Esposito, MD, PhD
      • Palermo, Italy, 90135
        • Recruiting
        • Maria Eleonora Hospital
        • Contact:
          • Giuseppe Vadalà, MD
      • Roma, Italy, 00161
        • Not yet recruiting
        • Azienda Policlinico Umberto I di Roma
        • Contact:
          • Fabrizio Fanelli, MD
      • Torino, Italy, 10132
        • Active, not recruiting
        • Maria Pia Hospital
    • Avellino
      • Mercogliano, Avellino, Italy, 83013
        • Not yet recruiting
        • Casa di Cura Montevergine
        • Contact:
          • Angelo Cioppa, MD
    • Genova
      • Rapallo, Genova, Italy, 16035
        • Active, not recruiting
        • ICLAS
    • Ravenna
      • Cotignola, Ravenna, Italy, 48033
        • Recruiting
        • Maria Cecilia Hospital
        • Contact:
          • Antonio Micari, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Symptomatic patients with ischemic vascular disease presenting with TASC C and D.

Description

Inclusion Criteria:

  1. Documented obstructive ischemic, symptomatic arterial disease in the femoral-popliteal arteries according to Rutherford Category 2, 3 or 4
  2. Target lesion consists of a single solitary or multiple adjacent de novo or re-stenotic lesions (non-in-stent) with diameter stenosis ≥ 70% by visual estimate and cumulative lesion length ≥ 15 cm
  3. Target vessel is the superficial femoral artery and/or popliteal artery (P1-2-3)
  4. Life expectancy >1 year in the Investigator's opinion
  5. Written informed consent

Exclusion Criteria:

  1. Patient unwilling or unlikely to comply with FU schedule
  2. Administration of local or systemic thrombolytic therapy within 48 hours prior to the index procedure
  3. Known allergies or sensitivities to heparin, aspirin, other anticoagulant/antiplatelet therapies, and/or paclitaxel
  4. Additional planned cardiac or peripheral percutaneous or surgical intervention including CABG within 30 days following the study procedure
  5. ≥15 cm long inflow lesion (≥50% DS)
  6. Failure to successfully treat < 15 cm long inflow lesion in the ipsilateral Iliac artery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of primary patency
Time Frame: 12 months after percutaneous treatment
Primary patency is defined as freedom from the combined endpoints of clinically-driven target lesion revascularization (TLR) and >50% restenosis in the treated lesion.
12 months after percutaneous treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
composite of all Major Adverse Events (MAE)
Time Frame: 24 months after percutaneous treatment
Incidence of the composite of all Major Adverse Events (MAE) through 24 months
24 months after percutaneous treatment
Incidence of Major Adverse Events (MAE)
Time Frame: 36 months after percutaneous treatment
Incidence of Major Adverse Events (MAE) through 36 months
36 months after percutaneous treatment
Clinical improvement as assessed by Rutherford Class changes
Time Frame: 6, 12, 24 and 36 months vs baseline
Clinical improvement as assessed by Rutherford Class changes
6, 12, 24 and 36 months vs baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of instrumental restenosis
Time Frame: Post-Procedure
Rate of instrumental restenosis as determined by duplex ultrasound Peak Systolic Velocity Ratio (PSVR) > 2 post-index procedure evaluated by an independent core lab
Post-Procedure
Procedural success rate
Time Frame: end of percutaneous procedure
Rate of procedural success in the absence of peri-procedural complications
end of percutaneous procedure
Walking capacity and quality of life
Time Frame: 6, 12, 24 and 36 months post-procedure
walking capacity as assessed by walking impairment questionnaire (WIQ), and 6 minutes' walk test
6, 12, 24 and 36 months post-procedure
Rate of instrumental restenosis
Time Frame: 12, 24 and 36 months
Rate of instrumental restenosis as determined by duplex ultrasound Peak Systolic Velocity Ratio (PSVR) > 2 evaluated by an independent core lab
12, 24 and 36 months
Quality of Life
Time Frame: 6, 12, 24 and 36 months post-procedure
quality of life assessed by EQ5D questionnaire
6, 12, 24 and 36 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ettore Sansavini Health Science Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Antonio Micari, MD, Maria Cecilia Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ESREFO26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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