Evaluation of the Safety and Efficacy of the Multilayer Stent

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Evaluation of the Multilayer Flow Modulator (MFM) for Endovascular Thoracoabdominal Aneurysm Repair.

The objectives of the study is to determine the efficacy, safety and performance of the MFM and its delivery system in patients at high surgical risk presenting with a type II, III thoracoabdominal aneurysm, below the left subclavian and above the iliac bifurcation, according to the Crawford classification.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Valiant Thoracic Stent Graft With the Captivia Delivery System in the Treatment of Descending Thoracic Aortic Diseases (VALIANT CAPTIVIA France)

NCT01775046

Aortic Aneurysm, Thoracic Descending Thoracic Aortic Dissection Penetrating Ulcer +2 more

COMPLETED

Evaluation of the Valiant Captivia Physician Fenestrated Stent Graft System in Aortic Arch and Descending Thoracic Aorta Pathologies

NCT05479305

Penetrating Ulcer of Aorta Aneurysm Aortic Type B Aortic Dissection +1 more

RECRUITING NA

Endurant™ Stent Graft System in the Treatment of Infra-renal Abdominal Aortic Aneurysms (ENDURANT France)

NCT01526811

Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal +3 more

COMPLETED

Branched Thoracic Endovascular Grafts for the Treatment of Thoraco-abdominal Aortic

NCT01874197

Thoracoabdominal Aortic Aneurysm, Without Rupture

RECRUITING NA

eTryton Left Main Registry Tryton Side Branch Stent® Tmt of Denovo CAD in LM and CFX Arteries

NCT02765646

Left Main Coronary Artery Stenosis

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conventional treatments of thoracoabdominal aneurysm are medical treatments (based on hypertension control) on one hand and surgical treatment on the other hand.

The standard treatment is surgery consisting of an exclusion of the aneurysm with restoration of continuity by means of a prosthesis usually made of Dacron.

* The rates of surgical morbidity and mortality differ according to whether the patient is treated electively or in an emergency setting. The most feared complication is spinal cord ischemia inducing paraplegia.
* In elective surgery, operative mortality is estimated to be between 6% and 15% depending on the series, and around 50% to 60% of patients are treated in an emergency setting. The rate of neurological complications such as paraparesis or paraplegia is estimated to be between 3% and 15%.
* In addition to the above, the following major complications have been shown to have an impact on the morbidity of this major surgery (5% each):
* Bleeding requiring surgical hemostasis
* Respiratory distress syndrome requiring prolonged ventilation support
* Acute renal failure
* Infections
* Central neurological events (stroke and coma)
* Peripheral neurological events (sensory-motor deficits, paraparesis, paraplegia)

Analyses identify risk factors increasing the morbidity and mortality:

* Patients over 80 years
* Chronic obstructive pulmonary disease
* Renal failure
* Coronary artery disease
* Comorbidities (malignancy, etc.)

Compared to surgery, endovascular stenting reduces:

* Pulmonary morbidity (suppression of thoracotomy and ventilation), in patients with impaired lung function;
* Renal dysfunction;
* Myocardial failure;
* Risk of spinal cord ischemia and paraplegia.

However, this treatment has a number of limitations

* Availability of device in case of emergency
* Topography of the neck must be far enough from the left subclavian artery to allow satisfactory fixation of the stent and exclusion of the lesion;
* Obstruction of the branches near the aneurysm.

In the current available treatment for this pathology, there are still some disadvantages such as the difficulty of precise positioning of the prosthesis and its branches which must cover the aneurysm tissue without endoleaks. Each lesion having anatomical specificities, the device must be designed for each individual patient, and the operator's technical ability must be extreme. So, the current technique is difficult to reproduce, and any emergency treatment is impossible.

The multilayer flow modulator (non-covered) is the device used in this trial The complications mentioned above are inherent in the concept of covered stent treatment plus endoleaks that continues to fuel the aneurismal sac untreated, thus subject to the persistent risk of rupture. With this technique, the visceral arteries are occluded or have a retrograde flow (which pressurizes the aneurysm again).

The multilayer flow modulator (non-covered) treatment approach avoids the major problems mentioned above:

* It allows the aneurismal sac to thrombose whilst maintaining the patency of collateral branches arising from the aneurysm;
* It improves the flow in the collateral branches, which becomes laminar flow through a mechanism of hemodynamic pressure drop from layer to layer and an increase in speed by rolling;
* Deployment is easier and it is not different from peripheral stent deployment;
* The device is available in all sizes and all lengths that can be stored, allowing the management of emergencies.

The space-age 3D geometrical design of a Cardiatis multilayer flow modulator modifies flow within the aorta in a way that reduces pressure within the aneurysm thus collapsing the aneurismal sac while preserving any vital collateral circulation.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Aortic Aneurysm, Thoracoabdominal Thoracoabdominal Aortic Aneurysm Aortic Aneurysm, Thoracic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Thotaco-abdominal aneurysm

MFM

Group Type EXPERIMENTAL

MFM

Intervention Type DEVICE

Implantation of the MFM

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MFM

Implantation of the MFM

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Multilayer Flow Modulator Multilayer stent

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age \>18 years
* Life expectancy ≥ 12 months
* The patient or his legal representative has signed the informed consent form
* Thoracoabdominal aneurysm type 2 or 3 with vital collaterals and requiring intervention to prevent its rupture according to the criteria defined by consensus ("Expert Consensus Document on the Treatment of Descending Thoracic Aortic Disease Using Endovascular Stent-Grafts", Ann Thorac Surg 2008;85:S1-41)
* Contraindicated for open surgery, declared inoperable by the surgeon and anesthetist (statement signed by each doctor) and must have at least one of the following:

1. Age \> 80 years
2. ASA (American Society of Anesthesiologists) score ≥ 3
3. History of thoracic surgery or surgery of the abdominal aorta
4. Coronary artery disease (history of angina or myocardial infarction) with positive functional testing and coronary lesions for which revascularization is impossible or not indicated
5. Heart failure
6. Inoperable aortic stenosis
7. LVEF (Left Ventricular Ejection Fraction) \<40%;
8. chronic respiratory failure defined by one of the following criteria:

1. FEV (Forced expiratory volume) \<1.2 l / sec;
2. VC (Vital Capacity) \<50% of the predicted value according to age, sex and weight;
3. arterial blood gas analysis in the absence of oxygen: PaCO2 (Pression artérielle en CO2) \> 45 mmHg or PaO2 (Pression artérielle en O2) \<60 mmHg
4. Oxygen therapy
9. renal insufficiency if creatininaemia\> 200 micromol / l before injection of contrast product;
10. hostile abdomen, including presence of ascites or other signs of portal hypertension;
11. obesity.
* adequate arterial anatomy of aneurismal lesion access.

Exclusion Criteria

* medical contraindications to a local or general anesthesia and angiography;
* Life expectancy less than one year, or clinical follow-up impossible;
* congenital disorders of blood coagulation;
* intercurrent infection;
* allergy to aspirin, clopidogrel, or contrast agents;
* patient(s) included in another clinical study;
* patient pregnant or breastfeeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No