Mesh Stents Study in ILIAC Complex Lesions (IMS-Study) | NCT05377775

Studies
Mesh Stents Study in ILIAC Complex Lesions (IMS-Study)

NCT05377775

Sponsor

Medical University of Warsaw

Status

Unknown status

Last Update Posted

May 17, 2022Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Peripheral Arterial Disease
Iliac Artery Stenosis
Embolus Arterial
Ischemic Leg

Interventions

Iliac Stenting

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 10, 2022Estimated

Primary Completion Date

Oct 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Apr 29, 2022

First Submission Date that Met QC Criteria

May 16, 2022

First Posted Date

May 17, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 16, 2022

Last Update Posted Date

May 17, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Conventional Implantation of mesh stent	Experimental	Conventional Implantation of mesh stent in iliac stenosis with high-risk plaques	Device: Iliac Stenting

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Iliac Stenting	Device	Conventional Implantation of mesh stent in iliac stenosis with high-risk plaques	Conventional Implantation of mesh stent

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MACNE (Major Adverse Cardiac or Neurological Event )	In-hospital MACNE (death, stroke, myocardial infarction, acute limb or target organ ischemia)	48 hours after procedure

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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
- 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Piotr Myrcha, MD, PhD	Contact	+48 607 366 683		piotrmyr@poczta.fm
Izabela Taranta, PhD	Contact	0048‭508190957‬		iza.taranta@gmail.com

Overall Officials

Name	Affiliation	Role
Piotr Myrcha, Ass.Prof.	Medical University of Warsaw	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Universtity of Warsaw		Warsaw	Masovian Voivodeship	03-242	Poland

References Module

Citations

Not provided

Label	URL
Randomized trial comparing CGuard™ stent vs. Wallstent™	View source
Thirty-Day Results of the Novel CGuard-Covered Stent in Patients Undergoing Carotid Artery Stenting	View source
CGuard MicroNet-Covered "One-Size-Fits-All" Carotid Stent

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases