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A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting

ASSIST - A Study in SurvIvors of Type B Aortic Dissection Undergoing Stenting

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01407159
Acronym
ASSIST
Enrollment
40
Registered
2011-08-02
Start date
2011-11-30
Completion date
2014-01-31
Last updated
2014-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type B Aortic Dissection

Keywords

type b dissection, thoracic stentgraft, aortic stent, clinical and technical success, safety and feasibility of E-XL aortic stent

Brief summary

Cohort study according to national regulatory guidelines: Non-interventional, observational cohort study. Pair-matched comparison with patients chosen from historical series. To evaluate the clinical and technical success as well as the safety and feasibility of the E-XL aortic stent used in complicated type B aortic dissection in addition to a classic stentgraft in a single procedure.

Interventions

None listed

Sponsors

JOTEC GmbH
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

The clinical records of the patients mus support the following criteria: * Age \> 18 years * Type B dissection with expanding false lumen eligible for endovascular treatment which occured within 90 days prior to implantation * The endovascular treatment may be associated with a complementary surgical operation * The total diameter of the dissected aortic segment should not surpass 6cm, and have increased between 0.5 and 1cm within 1 month, prior to implantation * Visceral arteries involvement, i.e. perfusion of side branches via true or false lumen of type B dissection * Aortic kinking \< 90° * The patient must be available for the appropriate follow-up times for the duration of the study * Informed consent from patient or authorized relative The data of whose patients clinical records confirm one of the following conditions will not be considered in this study: * Patients with a contraindication as indicated in the instruction for use * Patients with chronic thrombocytopenia or ongoing anticoagulation * Patients with renal failure and/or creatinine \>2.4mg/dl immediately before the intervention * Patients in whom the false lumen is completely thrombosed * Patients with ongoing infection * Patients with ongoing cancer * Patients who are enrolled in a clinical study * Aortic landing zone diameter over 40 mm * Potentially emboligenic iliac and aortic atheroma lesions * Associated pathology with life expectancy of less than 24 months * Unstable infectious syndrome

Design outcomes

Primary

MeasureTime frame
To evaluate the clinical and technical success as well as the safety and feasibility of the E-XL aortic stent used in complicated type B aortic dissection in addition to a classic thoracic stent-graft in a single procedure.February 2014

Countries

Germany, Italy, Poland, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026