Trial Outcomes & Findings for Removal of the Evolution® Esophageal Stent - Fully Covered (NCT NCT01900691)
NCT ID: NCT01900691
Last Updated: 2022-09-13
Results Overview
The study design allowed for 130 patients to be enrolled to ensure that 58 patients had an attempted endoscopic stent removal between 7 days and 6 months in order to assess the primary measure as per sample size calculation. Therefore, the first 58 patients (malignant or benign lesions) with data submitted regarding attempted endoscopic stent removal are included in this outcome measure. Successful stent removal is one in which the study stent is completely removed from the patient during a single endoscopic procedure with the wire mesh integrity maintained such that the stent can be removed in one contiguous piece. Additionally, successful stent removal includes no tissue damage or hemorrhage visible during the retrieval procedure that is both related to the endoscopic stent removal and requires immediate treatment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
130 participants
Primary outcome timeframe
7 days to 6 months
Results posted on
2022-09-13
Participant Flow
Participant milestones
| Measure |
Evolution® Esophageal Stent
Evolution® Esophageal Stent - Fully Covered: Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal
|
|---|---|
|
Overall Study
STARTED
|
130
|
|
Overall Study
COMPLETED
|
111
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Evolution® Esophageal Stent
Evolution® Esophageal Stent - Fully Covered: Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal
|
|---|---|
|
Overall Study
Death
|
7
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Study Device Not Placed
|
3
|
|
Overall Study
Non study stent placed
|
2
|
|
Overall Study
Six month Follow up completed, stent not removed
|
2
|
|
Overall Study
Complete stent migration through digestive tract
|
1
|
Baseline Characteristics
Removal of the Evolution® Esophageal Stent - Fully Covered
Baseline characteristics by cohort
| Measure |
Evolution® Esophageal Stent
n=130 Participants
Evolution® Esophageal Stent - Fully Covered: Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal
|
|---|---|
|
Age, Continuous
|
61.1 years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Black
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
103 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 days to 6 monthsThe study design allowed for 130 patients to be enrolled to ensure that 58 patients had an attempted endoscopic stent removal between 7 days and 6 months in order to assess the primary measure as per sample size calculation. Therefore, the first 58 patients (malignant or benign lesions) with data submitted regarding attempted endoscopic stent removal are included in this outcome measure. Successful stent removal is one in which the study stent is completely removed from the patient during a single endoscopic procedure with the wire mesh integrity maintained such that the stent can be removed in one contiguous piece. Additionally, successful stent removal includes no tissue damage or hemorrhage visible during the retrieval procedure that is both related to the endoscopic stent removal and requires immediate treatment.
Outcome measures
| Measure |
Evolution® Esophageal Stent
n=58 Participants
Evolution® Esophageal Stent - Fully Covered: Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal
|
|---|---|
|
Number of Patients With Successful Removal of Study Stent
|
57 Participants
|
SECONDARY outcome
Timeframe: 7 daysThe rate of clinical success in patients with strictures that showed improvement or relief of dysphagia symptoms or a seal sufficient to enable oral intake in patients with fistulas, perforations, or leaks.
Outcome measures
| Measure |
Evolution® Esophageal Stent
n=78 Participants
Evolution® Esophageal Stent - Fully Covered: Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal
|
|---|---|
|
Number of Patients With Benign Indications That Achieved Clinical Success
|
44 Participants
|
Adverse Events
Evolution® Esophageal Stent
Serious events: 46 serious events
Other events: 94 other events
Deaths: 10 deaths
Serious adverse events
| Measure |
Evolution® Esophageal Stent
n=130 participants at risk
Evolution® Esophageal Stent - Fully Covered: Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal
|
|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Cardiac disorders
Cardic Arrythmia
|
2.3%
3/130 • Number of events 3 • 6 months or removal of stent from patient (whichever comes first)
|
|
Gastrointestinal disorders
Dysphagia
|
4.6%
6/130 • Number of events 6 • 6 months or removal of stent from patient (whichever comes first)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Blood and lymphatic system disorders
Retroperitoneal lymph adenopathy
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
5/130 • Number of events 5 • 6 months or removal of stent from patient (whichever comes first)
|
|
Gastrointestinal disorders
Constipation
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Gastrointestinal disorders
Diarrhea
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Gastrointestinal disorders
Erosive esophagitis
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Gastrointestinal disorders
Gastric perforation
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.3%
3/130 • Number of events 3 • 6 months or removal of stent from patient (whichever comes first)
|
|
Gastrointestinal disorders
Hematemesis
|
1.5%
2/130 • Number of events 2 • 6 months or removal of stent from patient (whichever comes first)
|
|
Gastrointestinal disorders
Intestinal ischemia
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Gastrointestinal disorders
Malignant gastrointestinal obstruction
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Gastrointestinal disorders
Nausea
|
2.3%
3/130 • Number of events 3 • 6 months or removal of stent from patient (whichever comes first)
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Gastrointestinal disorders
Esophageal perforation
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
5/130 • Number of events 5 • 6 months or removal of stent from patient (whichever comes first)
|
|
General disorders
Asthenia
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
General disorders
Chest discomfort
|
2.3%
3/130 • Number of events 3 • 6 months or removal of stent from patient (whichever comes first)
|
|
General disorders
Chest pain
|
5.4%
7/130 • Number of events 7 • 6 months or removal of stent from patient (whichever comes first)
|
|
General disorders
Complication associated with device
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
General disorders
Malaise
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
General disorders
Non-cardiac chest pain
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
General disorders
Sensation of foreign body
|
3.1%
4/130 • Number of events 4 • 6 months or removal of stent from patient (whichever comes first)
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Immune system disorders
Drug hypersensitivity
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Infections and infestations
Abdominal absces
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Infections and infestations
Bacteremia
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Infections and infestations
Bronchitis
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Infections and infestations
Clostridium difficile infection
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Gastrointestinal disorders
Volvulus
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Infections and infestations
Fungemia
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Infections and infestations
Lung abscess
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Infections and infestations
Pneumonia
|
4.6%
6/130 • Number of events 7 • 6 months or removal of stent from patient (whichever comes first)
|
|
Infections and infestations
Sepsis
|
2.3%
3/130 • Number of events 3 • 6 months or removal of stent from patient (whichever comes first)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Infections and infestations
Urinary tract infection
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Infections and infestations
Urossepsis
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Injury, poisoning and procedural complications
Pharyngeal prforation
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Injury, poisoning and procedural complications
Post procedural hypotension
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Injury, poisoning and procedural complications
Procedural pneumothorax
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Injury, poisoning and procedural complications
Radiation pericarditis
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.5%
2/130 • Number of events 3 • 6 months or removal of stent from patient (whichever comes first)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.77%
1/130 • Number of events 2 • 6 months or removal of stent from patient (whichever comes first)
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Esophageal adenocarcinoma recurrent
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Product Issues
Device dislocation
|
7.7%
10/130 • Number of events 10 • 6 months or removal of stent from patient (whichever comes first)
|
|
Psychiatric disorders
Confusional state
|
0.77%
1/130 • Number of events 2 • 6 months or removal of stent from patient (whichever comes first)
|
|
Renal and urinary disorders
Acute kidney injury
|
1.5%
2/130 • Number of events 2 • 6 months or removal of stent from patient (whichever comes first)
|
|
Renal and urinary disorders
Bladder outlet obstruction
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.3%
3/130 • Number of events 3 • 6 months or removal of stent from patient (whichever comes first)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal compression
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Surgical and medical procedures
Central venous catheterization
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Surgical and medical procedures
Gastrointestinal tube insertion
|
0.77%
1/130 • Number of events 1 • 6 months or removal of stent from patient (whichever comes first)
|
|
Vascular disorders
Hypotension
|
0.77%
1/130 • Number of events 2 • 6 months or removal of stent from patient (whichever comes first)
|
Other adverse events
| Measure |
Evolution® Esophageal Stent
n=130 participants at risk
Evolution® Esophageal Stent - Fully Covered: Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal
|
|---|---|
|
Gastrointestinal disorders
Dysphagia
|
15.4%
20/130 • Number of events 20 • 6 months or removal of stent from patient (whichever comes first)
|
|
Product Issues
Device dislocation
|
64.6%
84/130 • Number of events 84 • 6 months or removal of stent from patient (whichever comes first)
|
|
General disorders
Chest pain
|
6.9%
9/130 • Number of events 9 • 6 months or removal of stent from patient (whichever comes first)
|
Additional Information
Alan Saunders, MDR, RAC; Manager, Biostatistics
Cook Research Incorporated
Phone: 765-463-7537
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60