NCT03129750

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2016

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2020

Completed
Last Updated

June 8, 2017

Status Verified

June 1, 2017

Enrollment Period

1.1 years

First QC Date

September 30, 2016

Last Update Submit

June 7, 2017

Conditions

PAD

Outcome Measures

Primary Outcomes (1)

  • Rate of primary patency

    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 Outcomes (3)

  • composite of all Major Adverse Events (MAE)

    24 months after percutaneous treatment

  • Incidence of Major Adverse Events (MAE)

    36 months after percutaneous treatment

  • Clinical improvement as assessed by Rutherford Class changes

    6, 12, 24 and 36 months vs baseline

Other Outcomes (5)

  • Rate of instrumental restenosis

    Post-Procedure

  • Procedural success rate

    end of percutaneous procedure

  • Walking capacity and quality of life

    6, 12, 24 and 36 months post-procedure

  • +2 more other outcomes

Interventions

Drug Coated BalloonDEVICE

Peripheral PTA with a drug coated balloon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Documented obstructive ischemic, symptomatic arterial disease in the femoral-popliteal arteries according to Rutherford Category 2, 3 or 4
  • 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
  • Target vessel is the superficial femoral artery and/or popliteal artery (P1-2-3)
  • Life expectancy \>1 year in the Investigator's opinion
  • Written informed consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Casa di Cura Montevergine

Mercogliano, Avellino, 83013, Italy

NOT YET RECRUITING

ICLAS

Rapallo, Genova, 16035, Italy

ACTIVE NOT RECRUITING

Maria Cecilia Hospital

Cotignola, Ravenna, 48033, Italy

RECRUITING

Santa Maria Hospital

Bari, 70124, Italy

NOT YET RECRUITING

A.O.U. Policlinico Vittorio Emanuele

Catania, 95123, Italy

RECRUITING

Città di Lecce Hospital

Lecce, 73100, Italy

RECRUITING

Policlinico Federico II

Napoli, 80131, Italy

NOT YET RECRUITING

Maria Eleonora Hospital

Palermo, 90135, Italy

RECRUITING

Azienda Policlinico Umberto I di Roma

Roma, 00161, Italy

NOT YET RECRUITING

Maria Pia Hospital

Torino, 10132, Italy

ACTIVE NOT RECRUITING

Study Officials

  • Antonio Micari, MD

    Maria Cecilia Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Salomone, MD

CONTACT

+390545217031msalomone@esrefo.org

Maria Letizia Lunetto, D.Sc.PT

CONTACT

+390545217032llunetto@ricercascientifica.org

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2016

First Posted

April 26, 2017

Study Start

August 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2020

Last Updated

June 8, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(10)