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Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms
NA trial testing GORE® EXCLUDER® Conformable AAA Endoprosthesis in Aortic Aneurysm, Abdominal in 175 participants. Participants enrolled and being followed up; not accepting new ones.
| Lead sponsor | W.L.Gore & Associates |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 175 |
| Start date | 19 December 2017 |
| Primary completion | 25 May 2023 |
| Estimated completion | 31 December 2027 |
| Sites | 51 locations across United States |
W.L.Gore & Associates — full company profile →
21 and older, any sex, with Aortic Aneurysm, Abdominal. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The primary safety endpoint event includes a composite of the following: * Death * Stroke * Myocardial Infarction * Bowel Ischemia * Paraplegia * Respiratory Failure * Renal Failure * Procedural Blood Loss \> 1000 mL * Thromboembolic events (including limb occlusion and distal embolic events)
| Group | Value | 95% CI |
|---|---|---|
| Short Neck Substudy | 79 | |
| High Neck Angulation Substudy | 89 |
The Primary Effectiveness Endpoint of device treatment success is a composite of technical success (successful access and deployment of all required GORE® EXCLUDER® Conformable AAA Endoprosthesis components) and freedom from: * Type I endoleak in the 12 month window * Type III endoleak in the 12 month window * Migration (10 mm or more) at the 12 month window (relative to post-operative baseline) * AAA enlargement ≥5 mm with or without intervention at the 12 month window (relative to post-operative baseline) * AAA rupture through the 12 month window * Conversion to open repair through the 12 m
| Group | Value | 95% CI |
|---|---|---|
| Short Neck Substudy | 65 | |
| High Neck Angulation Substudy | 73 |
Defined as estimated blood loss recorded during the endovascular procedure \> 1000 mL
| Group | Value | 95% CI |
|---|---|---|
| Short Neck Substudy | 0 | |
| High Neck Angulation Substudy | 3 |
Defined as time to discharge for initial procedural hospitalization
| Group | Value | 95% CI |
|---|---|---|
| Short Neck Substudy | 1.0 | 1 – 4 |
| High Neck Angulation Substudy | 1.0 | 1 – 13 |
Defined as time from first arterial access in the groin to the closure of the final access vessel
| Group | Value | 95% CI |
|---|---|---|
| Short Neck Substudy | 84.0 | 33 – 251 |
| High Neck Angulation Substudy | 110 | 40 – 358 |
Median blood loss at index procedure
| Group | Value | 95% CI |
|---|---|---|
| Short Neck Substudy | 50 | 0 – 1000 |
| High Neck Angulation Substudy | 50 | 0 – 2700 |
Successful access and deployment of all required CEXC device components, comprised of all the following: * Successful access * Successful deployment of Device endoprostheses in the intended anatomical location * Successful removal of all device delivery catheters from the patient * Patent Device components on completion angiography * Absence of Type I or Type III endoleak on completion angiography * Successful access site closure
| Group | Value | 95% CI |
|---|---|---|
| Short Neck Substudy | 80 | |
| High Neck Angulation Substudy | 93 |
Time frame: Up to 5 years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Short Neck Substudy | High Neck Angulation Subst… |
|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Stent-graft endoleak type II | General disorders | — | — |
| Unknown cause of death | General disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Chronic obstructive pulmonary disease exacerbation | Respiratory, thoracic and mediastinal disorders | — | — |
| Congestive cardiac failure aggravated | Cardiac disorders | — | — |
| Weakness generalized | General disorders | — | — |
| COVID-19 pneumonia | Infections and infestations | — | — |
| Sepsis | Infections and infestations | — | — |
| Septic shock | Infections and infestations | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — |
| Lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Syncope | Nervous system disorders | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — |
| Acute hypoxic respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | — | — |
| Atrial fibrillation | Cardiac disorders | — | — |
| Bradycardia | Cardiac disorders | — | — |
| Congestive heart failure | Cardiac disorders | — | — |
| Coronary artery disease | Cardiac disorders | — | — |
| Non ST segment elevation myocardial infarction | Cardiac disorders | — | — |
| Gastric ulcer | Gastrointestinal disorders | — | — |
| Lower gastrointestinal bleeding | Gastrointestinal disorders | — | — |
| Pancreatitis | Gastrointestinal disorders | — | — |
| Reaction | System | Short Neck Substudy | High Neck Angulation Subst… |
|---|---|---|---|
| Stent-graft endoleak type II | General disorders | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Urinary retention | Renal and urinary disorders | — | — |
Most-reported serious reactions: Anemia, Pneumonia, Stent-graft endoleak type II, Unknown cause of death, Urinary tract infection, Chronic obstructive pulmonary disease exacerbation, Congestive cardiac failure aggravated, Weakness generalized.
Data from ClinicalTrials.gov NCT02489539 adverse events section.
The purpose of the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by separate performance goals.
No peer-reviewed publications indexed yet for this trial.
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