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European (EU) Post Approval Study of the INCRAFT® AAA Stent Graft System in Subjects With Abdominal Aortic Aneurysms
trial testing Endovascular abdominal aortic aneurysm repair in Abdominal Aortic Aneurysms in 150 participants. Completed in 9 December 2021.
| Lead sponsor | Cordis US Corp. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 150 |
| Start date | 30 March 2015 |
| Primary completion | 24 October 2016 |
| Estimated completion | 9 December 2021 |
| Sites | 23 locations across France, Italy, Netherlands, Sweden, Ireland, United Kingdom, Germany, Spain |
Cordis US Corp. — full company profile →
18 and older, any sex, with Abdominal Aortic Aneurysms. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
MAE rate through 30 days includes Death, Stroke/CVA, Myocardial Infarction, New onset renal failure (requiring dialysis)
| Group | Value | 95% CI |
|---|---|---|
| InCraft® - AAA Stent Graft System | 0 | 0.0 – 2.4 |
MAE rate through 5 year includes Death, Stroke/CVA, Myocardial Infarction, New onset renal failure (requiring dialysis)
| Group | Value | 95% CI |
|---|---|---|
| InCraft® - AAA Stent Graft System | 44 | 33.604 – 55.304 |
successful insertion of the delivery system through the vasculature and successful deployment of the device at the intended location
| Group | Value | 95% CI |
|---|---|---|
| InCraft® - AAA Stent Graft System | 149 |
defined as absence of type I or III endoleaks and absence of aneurysm enlargement (growth \>5mm compared to the 1-month size measurement) within 1-year post-procedure as assessed by the core lab
| Group | Value | 95% CI |
|---|---|---|
| InCraft® - AAA Stent Graft System | 108 | 101.085 – 112.125 |
Single Arm EVAR Subjects who underwent procedure for the implant of InCraft® - AAA Stent Graft System
| Group | Value | 95% CI |
|---|---|---|
| Absence of Stent-graft Migration (>10 mm) Assessed at 1-year | 122 | 118.4 – 122 |
| Group | Value | 95% CI |
|---|---|---|
| InCraft® - AAA Stent Graft System | 141 |
| Group | Value | 95% CI |
|---|---|---|
| Absence of Stent-graft Migration (>10 mm) Assessed at 1-year | 138 |
Duration of INCRAFT procedure is from bifurcate insertion to completion of angiography
| Group | Value | 95% CI |
|---|---|---|
| InCraft® - AAA Stent Graft System | 42.3 | 39.4 – 45.2 |
| Group | Value | 95% CI |
|---|---|---|
| InCraft® - AAA Stent Graft System | 17.3 | 15.9 – 18.8 |
| Group | Value | 95% CI |
|---|---|---|
| InCraft® - AAA Stent Graft System | 99.4 | 92.0 – 106.7 |
Time frame: Adverse events are collected from index procedure until completion of study or early termination. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | INSIGHT |
|---|---|---|
| Cardiac disorders | Cardiac disorders | — |
| Infections and infestations | Infections and infestations | — |
| Gastrointestinal disorders | Gastrointestinal disorders | — |
| Nervous system disorders | Nervous system disorders | — |
| Vascular disorders | Vascular disorders | — |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | — |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | — |
| Hepatobiliary disorders | Hepatobiliary disorders | — |
| General disorders and administration site conditions | General disorders | — |
| Immune system disorders | Immune system disorders | — |
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | — |
| Renal and urinary disorders | Renal and urinary disorders | — |
| Surgical and medical procedures | Surgical and medical procedures | — |
| Reaction | System | INSIGHT |
|---|---|---|
| Vascular disorders | Vascular disorders | — |
| General disorders and administration site conditions | General disorders | — |
| Gastrointestinal disorders | Gastrointestinal disorders | — |
| Infections and infestations | Infections and infestations | — |
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | — |
| Cardiac arrhythmias | Cardiac disorders | — |
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | — |
| Renal and urinary disorders | Renal and urinary disorders | — |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | — |
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | — |
| Congenital, familial and genetic disorders | Congenital, familial and genetic disorders | — |
| Eye disorders | Eye disorders | — |
| Hepatobiliary disorders | Hepatobiliary disorders | — |
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | — |
| Neoplasms benign, malignant and unspecified (including cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — |
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | — |
| Investigations | Investigations | — |
| Nervous system disorders | Nervous system disorders | — |
| Product issues | Product Issues | — |
| Psychiatric disorders | Psychiatric disorders | — |
| Reproductive system and breast disorders | Reproductive system and breast disorders | — |
| Surgical and medical procedures | Surgical and medical procedures | — |
Most-reported serious reactions: Cardiac disorders, Infections and infestations, Gastrointestinal disorders, Nervous system disorders, Vascular disorders, Injury, poisoning and procedural complications, Neoplasms benign, malignant and unspecified (including cysts and polyps), Respiratory, thoracic and mediastinal disorders.
Data from ClinicalTrials.gov NCT02477111 adverse events section.
INSIGHT is a postmarket clinical follow-up study in the European Union. The purpose of the study is to continue to evaluate the safety and effectiveness/performance of INCRAFT in subjects with abdominal aortic aneurysms requiring endovascular repair in routine clinical practice. Approximately 150 subjects will be enrolled and followed through 5-years post procedure. Up to 25 sites in Europe may participate.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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