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

• Sponsor: Ospedale San Donato (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04594889
• Collaborator: (none)
• Enrollment: 170
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 26.5
• Patients Per Site Per Month: 6.4

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Anticipated 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
• Anticipated Study Start Date: Oct 14, 2020
• Anticipated Primary Completion Date: Jul 31, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Late Luminal Loss (LLL) [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 [12 months]

   amputation of target limb that requires a prostesis for standing and walking

2. Clinically driven target lesion revascularization [12 months]

   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

3. Target vessel occlusion (TVO) [12 months]

   TVO will be documented by duplex ultrasond examination

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Ospedale San Donato	Arezzo	AR	Italy	52100

Sponsors and Collaborators

• Ospedale San Donato

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Oct 20, 2020
• Last Update Posted: Oct 22, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, Cardiovascular Intervention Director, Ospedale San Donato: CLI
• Additional relevant MeSH terms: Ischemia

Study Results

No Results Posted as of Oct 22, 2020