Drug Coated BalloonDCBNCT04737291
Drug Coated Ballon in Critical Limb Ischemia
A study testing drug coated balloon in people with Drug Coated Balloon, run by Assiut University.
Trial summary
Evaluate the safety and efficacy of drug coated balloon (DCB) for the treatment of femoropopliteal lesions in patients with critical limb ischemia (CLI) Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Drug Coated Balloon
- What is being tested?
- drug coated balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2021to Mar 2023
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults at least 18 years of age with critical lower limb ischemia (Rutherford category 4, 5), stenotic (≥70% by visual angiographic assessment) or occlusive lesions in the native SFA or PPA, and vessel diameter ≥4 and ≤6 mm were eligible.
- Total lesion length ≤190 mm (visual angiographic assessment).
- DE novo angioplasty
- Recurrent or recoil lesion
Who cannot join
- pregnancy
- breast feeding
- iliac lesions
- Malignancy
- Patients with raised renal chemistry.
- Patients with contraindication to antiplatelet therapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Outcomes of Drug Coated Balloon Angioplasty for Femoropopliteal Lesions in Patients With Critical Limb Ischemia
Evaluate the safety and efficacy of drug coated balloon (DCB) for the treatment of femoropopliteal lesions in patients with critical limb ischemia (CLI)
Read the detailed description
Critical limb ischemia (CLI) is the most advanced stage of peripheral artery disease (PAD); which is estimated to affect more than 200 million people worldwide.(1) CLI classified as Rutherford category (RC) 4-6, includes ischemic rest pain and tissue loss.(2) The first line revascularization strategy for patients with CLI is endovascular percutaneous transluminal angioplasty (PTA).(3) The treatment of femoropopliteal lesions displays a huge anatomic challenge as this segment serves various biomechanical functions, Which makes endovascular treatment is challenging.(4) Plain balloon (PB) angioplasty for femoropopliteal artery disease has a high rate of procedural success and an acceptable safety profile, in spite of initially encouraging technical success after femoropopliteal (PTA), postprocedural restenosis remains the major challenge(5) Excessive extracellular matrix material synthesized by activated smooth muscle cells (SMC) in the media of the arteries leads to Neointimal hyperplasia and restenosis.(6) Restenosis resulting in loss of primary patency, late lumen loss (LLL), occlusion and/or the need for target lesion revascularization (TLR).(7) Drug-coated balloons (DCBs) inhibit the neointimal hyperplasia, the biological mechanism of restenosis formation, by application of cytostatic agents in a local therapeutic concentration.(8) The antiproliferative paclitaxel (PTX) seems to be the most effective therapeutic agent for DCBs due to local retention in the arterial wall.(9)
- Conditions
- Drug Coated Balloon
- Being tested
- drug coated balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug coated balloonDevice
use of drug coated balloon in treatment of critical limb ischemia
| Study group | Role | What they receive |
|---|---|---|
| Angioplasty by DCB | Experimental | angioplasty of stenotic , ocluded or recoil segment using drug coated ballon Receives: Device: drug coated balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from device- and procedure-related mortality
mortality related to procedure
Measured: 30 days
30 days clinically driven target vessel revascularization
patency rate
Measured: 30 days
Secondary outcomes (2)
Major adverse events
major adverse events as amputation
Measured: 12 months
1 year clinically driven target vessel revascularization
patency rate
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 posted3 Feb 2021
- Study start15 Mar 2021 (estimated)
- Primary completionMar 2022 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Coated BalloonStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Nageeb, Assiut University
- Investigators
- hassan bakr, professor, Study chair, Assiut Universitymahmoud ismael, ass profesor, Study director, Assiut Universityosman mahmoud, lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737291
- Sponsor's protocol ID
- drug coated balloon
- Acronym
- DCB
- Status last verified
- Feb 2021
- First submitted
- 13 Jan 2021
- Last updated
- 3 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Drug Coated Balloon Angioplasty for Femoropopliteal Lesions in Patients With Critical Limb Ischemia
- ClinicalTrials.gov ID
- NCT04737291
- Acronym / sponsor ID
- DCB / drug coated balloon
- Conditions
- Drug Coated Balloon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Mar 2021 (estimated)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 3 Feb 2021 (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.
Evaluate the safety and efficacy of drug coated balloon (DCB) for the treatment of femoropopliteal lesions in patients with critical limb ischemia (CLI)
Detailed description
Critical limb ischemia (CLI) is the most advanced stage of peripheral artery disease (PAD); which is estimated to affect more than 200 million people worldwide.(1) CLI classified as Rutherford category (RC) 4-6, includes ischemic rest pain and tissue loss.(2) The first line revascularization strategy for patients with CLI is endovascular percutaneous transluminal angioplasty (PTA).(3) The treatment of femoropopliteal lesions displays a huge anatomic challenge as this segment serves various biomechanical functions, Which makes endovascular treatment is challenging.(4) Plain balloon (PB) angioplasty for femoropopliteal artery disease has a high rate of procedural success and an acceptable safety profile, in spite of initially encouraging technical success after femoropopliteal (PTA), postprocedural restenosis remains the major challenge(5) Excessive extracellular matrix material synthesized by activated smooth muscle cells (SMC) in the media of the arteries leads to Neointimal hyperplasia and restenosis.(6) Restenosis resulting in loss of primary patency, late lumen loss (LLL), occlusion and/or the need for target lesion revascularization (TLR).(7) Drug-coated balloons (DCBs) inhibit the neointimal hyperplasia, the biological mechanism of restenosis formation, by application of cytostatic agents in a local therapeutic concentration.(8) The antiproliferative paclitaxel (PTX) seems to be the most effective therapeutic agent for DCBs due to local retention in the arterial wall.(9)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Angioplasty by DCB | Experimental | Device: drug coated balloonangioplasty of stenotic , ocluded or recoil segment using drug coated ballon |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults at least 18 years of age with critical lower limb ischemia (Rutherford category 4, 5), stenotic (≥70% by visual angiographic assessment) or occlusive lesions in the native SFA or PPA, and vessel diameter ≥4 and ≤6 mm were eligible.
- Total lesion length ≤190 mm (visual angiographic assessment).
- DE novo angioplasty
- Recurrent or recoil lesion
Key exclusion criteria (6 listed)
- pregnancy
- breast feeding
- iliac lesions
- Malignancy
- Patients with raised renal chemistry.
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 |
|---|---|---|
| drug coated balloonuse of drug coated balloon in treatment of critical limb ischemia | Device | Angioplasty by DCB |
Primary outcome
Freedom from device- and procedure-related mortality
Time frame: 30 days
mortality related to procedure
30 days clinically driven target vessel revascularization
Time frame: 30 days
patency rate
2 secondary outcomes
Major adverse events
Time frame: 12 months
1 year clinically driven target vessel revascularization
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 3 Feb 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Drug Coated Balloon
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EVERO Drug-coated Balloon (DCB) Randomized Trial
Peripheral Vascular Disease, Peripheral Arterial Disease
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Computational μFR-Guided Versus Angiographic Guidance in Drug-Coated Balloon Angioplasty
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Drug-coated Balloons Versus Drug-eluting Stents for the Treatment of Femoropopliteal In-Stent Restenosis
Femoropopliteal In-Stent Restenosis (ISR)
Active, not recruitingPhase 3
A Clinical Trial to Assess the Agent Paclitaxel Coated PTCA Balloon Catheter for the Treatment of Subjects With In-Stent Restenosis (ISR)
In-Stent Restenosis
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.
hassan bakr, professor study chair
Assiut University
mahmoud ismael, ass profesor study director
Assiut University
osman mahmoud, lecturer principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing drug coated balloon in people with Drug Coated Balloon, run by Assiut University.
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 4 inclusion and 6 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 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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 ahmed nageeb, master (01096192891, a7mednageeb@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from device- and procedure-related mortality (time frame: 30 days). The study lists 2 primary outcomes in all. 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 3 Feb 2021.