Critical Limb IschemiaDebateBTKDuellNCT04594889
Comparison of Sirolimus vs Paclitaxel Drug Eluting Balloon for Below-the-knee Angioplasty in Critical Limb Ischemia
A study testing angioplasty in people with Critical Limb Ischemia and Drug Effect, run by Ospedale San Donato at 1 site in Italy.
Trial 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)… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Critical Limb Ischemia, Drug Effect
- What is being tested?
- angioplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteItaly
- Study dates
- 14 Oct 2020to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 -
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedale San Donato
Arezzo, AR, 52100
Francesco Liistro, MD, +393381904695, francescoliistro@hotmail.com
About this study
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.
Read the 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)
- Conditions
- Critical Limb Ischemia, Drug Effect
- Being tested
- angioplasty
- Keywords
- CLI
- Medical subject headings
- Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
angioplastyProcedure or surgery
Also called PTA
Balloon releasing a drug inflated in the target vessel
| Study group | Role | What they receive |
|---|---|---|
| Sirolimus | Experimental | Sirolimus eluting balloon will be inflated in the target vessel after optimal balloon angioplasty for at least 2 minutes Receives: Procedure: angioplasty |
| Paclitaxel | Active comparator | Paclkitaxel eluting balloon will be inflated in the target vessel after optimal balloon angioplasty for at least 2 minutes Receives: Procedure: angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
Major limb amputation
amputation of target limb that requires a prostesis for standing and walking
Measured: 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
Measured: 12 months
Target vessel occlusion (TVO)
TVO will be documented by duplex ultrasond examination
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start14 Oct 2020 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical Limb IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ospedale San Donato
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Liistro, Ospedale San Donato
- Investigators
- Francesco Liistro, MD, Principal investigator, Ospedale San Donato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04594889
- Sponsor's protocol ID
- N° 1916-22/09/2020
- Acronym
- DebateBTKDuell
- Status last verified
- Oct 2020
- First submitted
- 14 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sirolimus vs Paclitaxel Drug Eluting Balloon for Below-the-knee Angioplasty in Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT04594889
- Acronym / sponsor ID
- DebateBTKDuell / N° 1916-22/09/2020
- Conditions
- Critical Limb Ischemia, Drug Effect
- Keywords
- CLI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Ospedale San DonatoUniversity, hospital or other
- Study start
- 14 Oct 2020 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sirolimus | Experimental | Procedure: angioplastySirolimus eluting balloon will be inflated in the target vessel after optimal balloon angioplasty for at least 2 minutes |
| Paclitaxel | Active comparator | Procedure: angioplastyPaclkitaxel eluting balloon will be inflated in the target vessel after optimal balloon angioplasty for at least 2 minutes |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| angioplastyAlso: PTABalloon releasing a drug inflated in the target vessel | Procedure or surgery | Paclitaxel, Sirolimus |
Primary outcome
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
3 secondary outcomes
Major limb amputation
Time frame: 12 months
Clinically driven target lesion revascularization
Time frame: 12 months
Target vessel occlusion (TVO)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Liistro, MD principal investigator
Ospedale San Donato
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing angioplasty in people with Critical Limb Ischemia and Drug Effect, run by Ospedale San Donato at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesco Liistro, MD (+393381904695, francescoliistro@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late Luminal Loss (LLL) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.