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

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: Unknown
• Conditions: PAD
• Intervention / Treatment: Device: Drug Coated Balloon

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: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Maria Salomone, MD; Phone Number: +390545217031; Email: msalomone@esrefo.org
• Study Contact Backup: Name: Maria Letizia Lunetto, D.Sc.PT; Phone Number: +390545217032; Email: llunetto@ricercascientifica.org

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

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
composite of all Major Adverse Events (MAE)	Incidence of the composite of all Major Adverse Events (MAE) through 24 months	24 months after percutaneous treatment
Incidence of Major Adverse Events (MAE)	Incidence of Major Adverse Events (MAE) through 36 months	36 months after percutaneous treatment
Clinical improvement as assessed by Rutherford Class changes	Clinical improvement as assessed by Rutherford Class changes	6, 12, 24 and 36 months vs baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of instrumental restenosis	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	Rate of procedural success in the absence of peri-procedural complications	end of percutaneous procedure
Walking capacity and quality of life	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	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	quality of life assessed by EQ5D questionnaire	6, 12, 24 and 36 months post-procedure

Collaborators and Investigators

• Sponsor: Ettore Sansavini Health Science Foundation
• Investigators: Principal Investigator: Antonio Micari, MD, Maria Cecilia Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: September 30, 2016
• First Submitted That Met QC Criteria: April 21, 2017
• First Posted (Actual): April 26, 2017

Study Record Updates

• Last Update Posted (Actual): June 8, 2017
• Last Update Submitted That Met QC Criteria: June 7, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases
• Other Study ID Numbers: ESREFO26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO