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

NCT04594889 | Unknown DMC

• 1 other identifier: N° 1916-22/09/2020
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Limb Ischemia; Drug Effect

Keywords

CLI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Major limb amputation

  12 months

• Clinically driven target lesion revascularization

  12 months

• Target vessel occlusion (TVO)

  12 months

Study Arms (2)

Sirolimus

EXPERIMENTAL

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

Procedure: angioplasty

Paclitaxel

ACTIVE COMPARATOR

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

Procedure: angioplasty

Interventions

angioplasty PROCEDURE

Balloon releasing a drug inflated in the target vessel

Also known as: PTA

Paclitaxel; Sirolimus

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 85 years
• CLI Rutherford class 4-6.
• Stenosis or occlusion with length \>= 4 cm involving a tibial artery
• Presence of angiographic distal runoff to the foot (stage 1-2a-2b of the Kawarada classification)
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Ospedale San Donato: lead

Study Sites (1)

Ospedale San Donato

Arezzo, AR, 52100, Italy

RECRUITING

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Interventions

Angioplasty

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Francesco Liistro, MD

  Ospedale San Donato

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Liistro, MD

CONTACT

+393381904695; francescoliistro@hotmail.com

Paolo Angioli, MD

CONTACT

+390575255526; angiolipaolo@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Cardiovascular Intervention Director

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 20, 2020
• Study Start: October 14, 2020
• Primary Completion: July 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)