Peripheral Arterial DiseaseIMSNCT05377775
Mesh Stents Study in ILIAC Complex Lesions (IMS-Study)
A study testing Iliac Stenting in people with Peripheral Arterial Disease and Iliac Artery Stenosis, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
The main objective of the IMS-Study is to evaluate the short and long-term safety and efficacy of mesh stent implantation in patients with stenotic iliac disease with complex plaques or lesions containing thrombotic material. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Iliac Artery Stenosis, Embolus Arterial
- What is being tested?
- Iliac Stenting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePoland
- Study dates
- 10 Jun 2022to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General Inclusion Criteria (principal):
- Patients older than 18 years, after Vascular Team evaluation, according to local standards, eligible for Iliac artery
- Written, informed consent to participate
- Agreement to attend Protocol required (standard) follow up visits and examinations
- Angiographic Inclusion Criteria (principal):
- De novo iliac stenosis
- Stenosis eligible for endovascular treatment per Vascular Team evaluation (according to current standards and guidelines)
- High-risk morphology stenosis with complex/thrombotic lesions (per 1 independent, experienced operator).
Who cannot join
- General Exclusion Criteria (principal):
- Life expectancy <1 year (e.g., active neoplastic disease).
- Chronic kidney disease with creatinine > 3.0 mg/dL.
- Coagulopathy.
- Contraindication for decoagulation
- History of uncontrolled contrast media intolerance
Show all 14Show fewer
- Myocardial infarction in 72 hours preceding the stenting procedure (if possible, postponing the procedure)
- Stroke in 6 weeks preceding the stenting procedure (if possible, postponing the procedure)
- Pregnancy (positive pregnancy test)
- AngiographicExclusion Criteria (principal):
- Chronic total occlusion not amenable to re-canalization
- Stent in the target vessel/lesion
- Anatomic variants precluding stent implantation
- Mobile (free-floating) plaque elements in aorta or arteries proximal to the target lesion
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical Universtity of Warsaw
Warsaw, Masovian Voivodeship, 03-242
About this study
Official title: Mesh Stents Study in Iliac Complex Lesions Iliac-Mesh Stent Study (IMS-Study)
The main objective of the IMS-Study is to evaluate the short and long-term safety and efficacy of mesh stent implantation in patients with stenotic iliac disease with complex plaques or lesions containing thrombotic material.
Read the detailed description
Iliac artery disease may include complex lesions with a vulnerable plaque and containing thrombotic materials. The treatment of these complex plaques is frequently complicated with local, acute occlusion, dissection and distal embolisation.
Studies with a mesh stent in the carotid region have shown a reduced risk of peripheral embolization. The use of mesh stents in iliac arteries can provide similar benefits. The structure of the stents, sizes, and the release system do not require any changes. The study is to assess the usefulness of mesh stents in preventing peripheral embolisation.
- Being tested
- Iliac Stenting
- Keywords
- Iliac artery stenosis, High-risk plague, Mesh stent, Peripheral embolisation, Peripheral arterial disease
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iliac StentingDevice
Conventional Implantation of mesh stent in iliac stenosis with high-risk plaques
| Study group | Role | What they receive |
|---|---|---|
| Conventional Implantation of mesh stent | Experimental | Conventional Implantation of mesh stent in iliac stenosis with high-risk plaques Receives: Device: Iliac Stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACNE (Major Adverse Cardiac or Neurological Event )
In-hospital MACNE (death, stroke, myocardial infarction, acute limb or target organ ischemia)
Measured: 48 hours after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start10 Jun 2022 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-center, open-label, single-arm, non-randomized clinical trial.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piotr Myrcha, Ass.Prof., Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377775
- Sponsor's protocol ID
- WarsawMU IMS v.01
- Acronym
- IMS
- Status last verified
- Apr 2022
- First submitted
- 29 Apr 2022
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesh Stents Study in Iliac Complex Lesions Iliac-Mesh Stent Study (IMS-Study)
- ClinicalTrials.gov ID
- NCT05377775
- Acronym / sponsor ID
- IMS / WarsawMU IMS v.01
- Keywords
- Iliac artery stenosis, High-risk plague, Mesh stent, Peripheral embolisation, Peripheral arterial disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 10 Jun 2022 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 May 2022 (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 main objective of the IMS-Study is to evaluate the short and long-term safety and efficacy of mesh stent implantation in patients with stenotic iliac disease with complex plaques or lesions containing thrombotic material.
Detailed description
Iliac artery disease may include complex lesions with a vulnerable plaque and containing thrombotic materials. The treatment of these complex plaques is frequently complicated with local, acute occlusion, dissection and distal embolisation.
Studies with a mesh stent in the carotid region have shown a reduced risk of peripheral embolization. The use of mesh stents in iliac arteries can provide similar benefits. The structure of the stents, sizes, and the release system do not require any changes. The study is to assess the usefulness of mesh stents in preventing peripheral embolisation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-center, open-label, single-arm, non-randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Conventional Implantation of mesh stent | Experimental | Device: Iliac StentingConventional Implantation of mesh stent in iliac stenosis with high-risk plaques |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- General Inclusion Criteria (principal):
- Angiographic Inclusion Criteria (principal):
Key exclusion criteria (14 listed)
- General Exclusion Criteria (principal):
- AngiographicExclusion Criteria (principal):
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 |
|---|---|---|
| Iliac StentingConventional Implantation of mesh stent in iliac stenosis with high-risk plaques | Device | Conventional Implantation of mesh stent |
Primary outcome
MACNE (Major Adverse Cardiac or Neurological Event )
Time frame: 48 hours after procedure
In-hospital MACNE (death, stroke, myocardial infarction, acute limb or target organ ischemia)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Randomized trial comparing CGuard™ stent vs. Wallstent™Link provided by the sponsor.
- Thirty-Day Results of the Novel CGuard-Covered Stent in Patients Undergoing Carotid Artery StentingLink provided by the sponsor.
- CGuard MicroNet-Covered "One-Size-Fits-All" Carotid StentLink provided by the sponsor.
- The IRONGUARD 2 StudyLink provided by the sponsor.
- Analysis from the PARADIGM studyLink provided by the sponsor.
- 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.
Piotr Myrcha, Ass.Prof. principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iliac Stenting in people with Peripheral Arterial Disease and Iliac Artery Stenosis, run by Medical University of Warsaw at 1 site in Poland.
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 8 inclusion and 14 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 17 May 2022. 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 Poland. 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 Piotr Myrcha, MD, PhD (+48 607 366 683, piotrmyr@poczta.fm), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACNE (Major Adverse Cardiac or Neurological Event ) (time frame: 48 hours after procedure). 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 17 May 2022.