Comparison of Sirolimus vs Paclitaxel Drug Eluting Balloon for Below-the-knee Angioplasty in Critical Limb Ischemia (DebateBTKDuell)

The objective of this study is to compare the remote patency of paclitaxel versus sirolimus eluting balloons in patients with CLI undergoing tibial artery revascularization. Patients will be randomized 1:1 to Paclitaxel eluting balloon (Litos, ACOTEC ltd) or sirolimus eluting balloon (Magic touch, Concept Medical) after optimal balloon angioplasty. The primary endpoint of the study is the late luminal loss at 6 months angiography. Secondary endpoint are major amputation, clinically driven target lesion revascularization and vessel reocclusion (duplex) at 12 months.

Study Overview

• Status: Unknown
• Conditions: Drug Effect; Critical Limb Ischemia
• Intervention / Treatment: Procedure: angioplasty

Detailed Description

Critical ischemia of the limb is considered one of the most severe clinical scenario of atherosclerotic disease involving the lower limb because it is associated with a high degree of mortality and morbidity. Below the knee arterial disease is the basis of critical limb ischemia (CLI). It is generally characterized by the involvement of multiple tibial arteries, long lesions and high rate of hronic total occlusions. Percutaneous treatment of tibial arteriopathy is characterized by high restenosis (70%). The advent of the drug-eluting strategy has led to a reduction in the restenosis of the femoral and tibial district with paclitaxel eluting devices. Data are not yet available on sirolimus eluting devices, both for the femoropopliteal and tibial districts. The objective of this study is to compare the remote patency of paclitaxel (Lithos) vs. the sirolimus (magic touch) eluting balloons in patients with CLI undergoing tibial artery revascularization.

The study will enroll only patients with optimal balloon angioplasty defined by angiographic and ultrasound criteria in order to avoid biases related to potentially unbalanced suboptimal angioplasty results in both groups. The patients will be followed by either interventionalists as well as diabetic foot specialists in order to optimize their surveillance for lesion healings and vessel patency and reduced dropout.

Participating

Centers Cardiovascular disease department (San Donato Hospital, Arezzo, Italy) O.U. Cardiology (San Iacopo Hospital, Pistoia, Italy) O.U. Cardiology (San Giuseppe Hospital, Empoli, Italy) O.U Hemodynamics (A.O.U.C. Careggi, FlorenCe, Italy)

• Study Type: Interventional
• Enrollment (Anticipated): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • AR
    • Arezzo, AR, Italy, 52100
      • Recruiting
      • Ospedale San Donato
      • Contact: Francesco Liistro, MD; Phone Number: +393381904695; Email: francescoliistro@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age between 18 and 85 years
2. CLI Rutherford class 4-6.
3. Stenosis or occlusion with length >= 4 cm involving a tibial artery
4. Presence of angiographic distal runoff to the foot (stage 1-2a-2b of the Kawarada classification)
5. Presence of optimal angioplasty result defined as residual stenosis < 50%, absence of flow limiting dissection, absence of vessel perforation, absence of distal embolization by angiography and biphasic or triphasic flow at ultrasoud evaluation of the target vessel

Exclusion Criteria:

1. Known allergy to one of the drugs in the study
2. Contraindications to antiplatelet therapy
3. Life expectancy less than 1 year
4. Major amputation planned before angiography
5. Inability to obtain informed consent -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sirolimus; Sirolimus eluting balloon will be inflated in the target vessel after optimal balloon angioplasty for at least 2 minutes	Procedure: angioplasty; Balloon releasing a drug inflated in the target vessel; Other Names: PTA
ACTIVE_COMPARATOR: Paclitaxel; Paclkitaxel eluting balloon will be inflated in the target vessel after optimal balloon angioplasty for at least 2 minutes	Procedure: angioplasty; Balloon releasing a drug inflated in the target vessel; Other Names: PTA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late Luminal Loss (LLL)	LLL will be measured in the treated segment obtained subtracting the minimal lumen diameter at 6-month angiographic follow.up with minimal lumen diameter post intervention	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major limb amputation	amputation of target limb that requires a prostesis for standing and walking	12 months
Clinically driven target lesion revascularization	repeat intervention of the target segment due to vessel restenosis documented by angiography and the presence of symptoms as follows: non healing ulcer; rest pain of the treated limb	12 months
Target vessel occlusion (TVO)	TVO will be documented by duplex ultrasond examination	12 months

Collaborators and Investigators

• Sponsor: Ospedale San Donato
• Investigators: Principal Investigator: Francesco Liistro, MD, Ospedale San Donato

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 14, 2020
• Primary Completion (ANTICIPATED): July 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (ACTUAL): October 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: CLI
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: N° 1916-22/09/2020

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No