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

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ClinicalTrials.gov Identifier: NCT04594889
Recruitment Status : Unknown
Verified October 2020 by Francesco Liistro, Ospedale San Donato.
Recruitment status was:  Recruiting
First Posted : October 20, 2020
Last Update Posted : October 22, 2020
Sponsor:
Information provided by (Responsible Party):
Francesco Liistro, Ospedale San Donato

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Drug Effect Procedure: angioplasty Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Sirolimus vs Paclitaxel Drug Eluting Balloon for Below-the-knee Angioplasty in Critical Limb Ischemia
Estimated Study Start Date : October 14, 2020
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: PTA


Outcome Measures
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Primary Outcome Measures :
  1. Late Luminal Loss (LLL) [ Time Frame: 6 months ]
    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


Secondary Outcome Measures :
  1. Major limb amputation [ Time Frame: 12 months ]
    amputation of target limb that requires a prostesis for standing and walking

  2. Clinically driven target lesion revascularization [ Time Frame: 12 months ]

    repeat intervention of the target segment due to vessel restenosis documented by angiography and the presence of symptoms as follows:

    1. non healing ulcer
    2. rest pain of the treated limb

  3. Target vessel occlusion (TVO) [ Time Frame: 12 months ]
    TVO will be documented by duplex ultrasond examination


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 -
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04594889


Contacts
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Contact: Francesco Liistro, MD +393381904695 francescoliistro@hotmail.com
Contact: Paolo Angioli, MD +390575255526 angiolipaolo@hotmail.com

Locations
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Italy
Ospedale San Donato Recruiting
Arezzo, AR, Italy, 52100
Contact: Francesco Liistro, MD    +393381904695    francescoliistro@hotmail.com   
Sponsors and Collaborators
Ospedale San Donato
Investigators
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Principal Investigator: Francesco Liistro, MD Ospedale San Donato
More Information
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Responsible Party: Francesco Liistro, Cardiovascular Intervention Director, Ospedale San Donato
ClinicalTrials.gov Identifier: NCT04594889    
Other Study ID Numbers: N° 1916-22/09/2020
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Francesco Liistro, Ospedale San Donato:
CLI
Additional relevant MeSH terms:
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Ischemia
Pathologic Processes