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

PAD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03129750
• Other study ID #: ESREFO26
• Status: Recruiting
• Phase: N/A
• First received: September 30, 2016
• Last updated: June 7, 2017
• Start date: August 2016
• Est. completion date: September 2020

Study information

• Verified date: June 2017
• Source: Ettore Sansavini Health Science Foundation
• Contact: Maria Salomone, MD
• Phone: +390545217031
• Email: msalomone[@]esrefo.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2020
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PAD
• Vascular Diseases

Intervention

Device:
• Drug Coated Balloon
Peripheral PTA with a drug coated balloon

Locations

Country	Name	City	State
Italy	Santa Maria Hospital	Bari
Italy	A.O.U. Policlinico Vittorio Emanuele	Catania
Italy	Maria Cecilia Hospital	Cotignola	Ravenna
Italy	Città di Lecce Hospital	Lecce
Italy	Casa di Cura Montevergine	Mercogliano	Avellino
Italy	Policlinico Federico II	Napoli
Italy	Maria Eleonora Hospital	Palermo
Italy	ICLAS	Rapallo	Genova
Italy	Azienda Policlinico Umberto I di Roma	Roma
Italy	Maria Pia Hospital	Torino

Sponsors (1)

Lead Sponsor	Collaborator
Ettore Sansavini Health Science Foundation

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Procedural success rate	Rate of procedural success in the absence of peri-procedural complications	end of percutaneous procedure
Other	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
Other	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
Other	Quality of Life	quality of life assessed by EQ5D questionnaire	6, 12, 24 and 36 months post-procedure
Primary	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	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
Secondary	Incidence of Major Adverse Events (MAE)	Incidence of Major Adverse Events (MAE) through 36 months	36 months after percutaneous treatment
Secondary	Clinical improvement as assessed by Rutherford Class changes	Clinical improvement as assessed by Rutherford Class changes	6, 12, 24 and 36 months vs baseline