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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-14

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Critical Limb Ischemia Drug Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sirolimus

Sirolimus eluting balloon will be inflated in the target vessel after optimal balloon angioplasty for at least 2 minutes

Group Type EXPERIMENTAL

angioplasty

Intervention Type PROCEDURE

Balloon releasing a drug inflated in the target vessel

Paclitaxel

Paclkitaxel eluting balloon will be inflated in the target vessel after optimal balloon angioplasty for at least 2 minutes

Group Type ACTIVE_COMPARATOR

angioplasty

Intervention Type PROCEDURE

Balloon releasing a drug inflated in the target vessel

Interventions

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angioplasty

Balloon releasing a drug inflated in the target vessel

Intervention Type PROCEDURE

Other Intervention Names

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PTA

Eligibility Criteria

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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 -

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No