Patients presenting with chronic type B aortic dissection will have the MFM implanted.

Aortic Dissection Type B

Implantation with the Multilayer Flow Modulator (MFM)

City Clinic Burgas

City Clinic Sofia

European Hospital Polisano

Cukurova University Medical Faculty Balcali Hospital

Bezm-i Alem Vakif universitesi Tip Fakültesi Hastanesi

Kartal Kosuyolu Yuksek Ihtisas Research and Training Hospital

Dragon Study Europe

Evaluation of the Safety and Performance of the Multilayer Flow Modulator (MFM) for the Treatment of Chronic Type B Aortic Dissection

the re-establishment of the flow inside the true lumen will be evaluated using medical imagery. Data will be compaired to pre-op imaregy, and will be presented as a percentage of patient with true lumen repressurization compared to baseline.

the patency of branches emerging from the treated portion of the aorta will be evaluated and compared to pre-op data. Data will be presented as a percentage of branches patent per total number of branches involved in the diseased and treated portion of the aorta.

the re-establishment of the flow inside the true lumen will be evaluated using medical imagery. Data will be compared to pre-op imaregy, and will be presented as a percentage of patient with true lumen repressurization compared to baseline.

Percentage of patients deceased at 30 days

Successful delivery and deployment of the MFM

descriptive statistics on Anesthesia time (min)

Descriptive Statistics on fluoroscopy time (min)procedure time; time to hospital discharge

Descriptive Statistics on contrast volume (ml)

Descriptive Statistics on contrast Estimated Blood loss (ml)

Descriptive Statistics on procedure time (min)

Descriptive Statistics on time to hospital discharge (days).

Cardiatis

Dragon Study Europe is an international, multicenter, prospective, non-randomized study. It is designed to evaluate safety and performance of the MFM for the treatment of chronic type B aortic dissection. About 35 patients in up to 11 countries will be enrolled and screened per the protocol-required inclusion, exclusion criteria, in order to obtain 30 completed patients. The main interim analysis, aiming at the early demonstration of safety and performance, will be performed after all patients included will complete their 6-month follow-up. A preliminary interim analysis will be performed on the first patients enrolled (15 completed patients) and with their 6-months follow-up available.

Amyotrophic Lateral Sclerosis

Progressive Muscular Atrophy

Primary Lateral Sclerosis

Hereditary Spastic Paraplegia

This is a prospective 12-month study of patients with motor neuron disease enrolled in CReATe Connect, an RDCRN Contact Registry.

Web-based Survey

A Patient Centric Motor Neuron Disease Activities of Daily Living Scale

The PADL-ALS survey is a revision of the ALSFR-R, which consists of 12 categories detailing various activities of daily living and includes six bulbar-respiratory functions, three upper extremity functions (writing, cutting food, and dressing) and three gross motor functions (walking, climbing, and turning in bed). Each activity is recorded from a list of five choices, scored 0-4, with the total score ranging from 48 (normal function) to 0 (no function). The PADL-ALS includes questions from the ALSFRS-R, with revisions for easier understanding. The PADL-ALS also includes questions about pain, emotional lability and a general non-denominational question about faith. The survey is composed of an initial survey and monthly follow up surveys. The initial survey will include additional questions about symptom onset, date of diagnosis, initial region involved, patient impression of diagnosis, general demographic questions, and medications related to their diagnosis of motor neuron disease.

University of South Florida

National Institutes of Health (NIH)

University of Kansas

University of Miami

Degeneration

Shoulder Pain

Institute of Sportsmedicine

Symptoms of Degeneration in Shoulder of Wheelchair-users

Längsschnittstudie Zur Belastungsinduzierten Anpassung, Schädigung Oder Degeneration Der Schulter Bei Rollstuhlathleten/-Innen

Prof. Dr. Uwe Tegtbur

Hannover Medical School

this group will use no additional aid in transfer.

The standard transfer board is a flat surface board designed to bridge the gap that exists with transfers from wheelchair to vehicle and/or other horizontally displaced seating surfaces.

The Glide n' Go lift is a flip down power list seat that enables the person to enter and exit the vehicle by lifting them from their wheelchair up tot eh vehicle seat that they can make an easy transfer into the vehicle. Trunk stability may be required to successfully use the device.

The Easy Reach lift seat allows the vehicles original seat to swivel out of the vehicle and lower to wheelchair height. the chair extends far from the vehicle to provide access for a safe, easy transfer.

The Ryno lift is an under-vehicle list (UVL) system. Using this lift, the wheelchair user is raised into the vehicle cab using independent controls and can then maneuver into a convenient position in the cab. The wheelchair is locked down and the lift stored beneath the vehicle chassis. This technology eliminated the need to store and retrieve a wheelchair during transit.

Persons with SCI who evaluated wheelchair transfer interventions

Wheelchair Transfer Interventions

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

measurement of applied shoulder force during wheelchair transfers

As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study, but verifiable data is not available for any of the participants.

Glide n' Go

Standard Transfer Board

As of the November 2012 update to the IRB, 4 individuals were reported to actively take part in the study but verifiable data is not available for any of the participants.

Easy Reach Lift

Ryno Lift

Unassisted Manual Transfer

Shoulder Force

5 persons with SCI were recruited and provided informed consent. Four completed the protocol. One was dropped due to an unrelated injury to the subjects hand at his home.

Overall Study

John Lloyd

Group 1

Spinal Cord Injury

Original chair is converted to a chair that swivels out of the vehicle and lowers to wheelchair height

paraplegia/atrofia

Dragon Study Europe

A Patient Centric Motor Neuron Disease Activities of Daily Living Scale

Symptoms of Degeneration in Shoulder of Wheelchair-users

Biomechanics of Wheelchair Transfers

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