Trial Outcomes & Findings for Zilver® PTX® V Clinical Study (NCT NCT01901289)
NCT ID: NCT01901289
Last Updated: 2022-03-02
Results Overview
A reintervention performed for ≥ 50 % diameter stenosis within ± 5 mm proximal and /or distal to the target lesion after documentation of recurrent clinical symptoms of peripheral arterial disease (PAD) following the initial procedure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
1 year
Results posted on
2022-03-02
Participant Flow
Participant milestones
| Measure |
Drug-Eluting Stent
Zilver® PTX® Drug-Eluting Peripheral Stent: Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
|
|---|---|
|
Overall Study
STARTED
|
200
|
|
Overall Study
12-Month Follow-up
|
194
|
|
Overall Study
COMPLETED
|
115
|
|
Overall Study
NOT COMPLETED
|
85
|
Reasons for withdrawal
| Measure |
Drug-Eluting Stent
Zilver® PTX® Drug-Eluting Peripheral Stent: Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
|
|---|---|
|
Overall Study
Death
|
32
|
|
Overall Study
Lost to Follow-up
|
16
|
|
Overall Study
Withdrawal by Subject
|
35
|
|
Overall Study
Other type of endpoint met
|
2
|
Baseline Characteristics
Zilver® PTX® V Clinical Study
Baseline characteristics by cohort
| Measure |
Drug-Eluting Stent
n=200 Participants
Zilver® PTX® Drug-Eluting Peripheral Stent: Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
|
|---|---|
|
Age, Continuous
|
67.9 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
126 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/Caucasian or White
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian or White
|
165 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
200 participants
n=5 Participants
|
|
Diabetes
|
92 Participants
n=5 Participants
|
|
Smoking Status
Never smoked
|
31 Participants
n=5 Participants
|
|
Smoking Status
Quit smoking
|
86 Participants
n=5 Participants
|
|
Smoking Status
Still smoking
|
83 Participants
n=5 Participants
|
|
Hypercholesterolemia
|
173 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: The result was calculated using the Kaplan-Meier method (with Greenwood's formula for standard error).
A reintervention performed for ≥ 50 % diameter stenosis within ± 5 mm proximal and /or distal to the target lesion after documentation of recurrent clinical symptoms of peripheral arterial disease (PAD) following the initial procedure.
Outcome measures
| Measure |
Drug-Eluting Stent
n=200 Participants
Zilver® PTX® Drug-Eluting Peripheral Stent: Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
|
|---|---|
|
Patients Without Target Lesion Revascularization (TLR)
|
186 Participants
|
Adverse Events
Drug-Eluting Stent
Serious events: 154 serious events
Other events: 46 other events
Deaths: 32 deaths
Serious adverse events
| Measure |
Drug-Eluting Stent
n=200 participants at risk
Zilver® PTX® Drug-Eluting Peripheral Stent: Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.0%
4/200 • Number of events 4 • 5 years
|
|
Blood and lymphatic system disorders
Bandaemia
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Cardiac disorders
Acute left ventricular failure
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Cardiac disorders
Acute myocardial infarction
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Cardiac disorders
Angina pectoris
|
2.0%
4/200 • Number of events 4 • 5 years
|
|
Cardiac disorders
Angina unstable
|
2.0%
4/200 • Number of events 4 • 5 years
|
|
Cardiac disorders
Arrhythmia
|
3.5%
7/200 • Number of events 7 • 5 years
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
4/200 • Number of events 4 • 5 years
|
|
Cardiac disorders
Atrial flutter
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Cardiac disorders
Bradycardia
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Cardiac disorders
Cardiac arrest
|
1.0%
2/200 • Number of events 3 • 5 years
|
|
Cardiac disorders
Cardiac failure
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Cardiac disorders
Cardiac failure acute
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Cardiac disorders
Cardiac failure congestive
|
8.0%
16/200 • Number of events 25 • 5 years
|
|
Cardiac disorders
Cardiomyopathy
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Cardiac disorders
Coronary artery disease
|
2.5%
5/200 • Number of events 5 • 5 years
|
|
Cardiac disorders
Coronary artery stenosis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Cardiac disorders
Myocardial infarction
|
5.5%
11/200 • Number of events 13 • 5 years
|
|
Cardiac disorders
Myocardial ischaemia
|
10.0%
20/200 • Number of events 26 • 5 years
|
|
Cardiac disorders
Palpitations
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Cardiac disorders
Tachycardia
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Cardiac disorders
Ventricular tachycardia
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
4/200 • Number of events 6 • 5 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Abdominal wall haematoma
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Ascites
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Colitis
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Diarrhoea
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Duodenal ulcer perforation
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Dysphagia
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Femoral hernia
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
6.5%
13/200 • Number of events 16 • 5 years
|
|
Gastrointestinal disorders
Ileus
|
1.5%
3/200 • Number of events 3 • 5 years
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.5%
3/200 • Number of events 4 • 5 years
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Intestinal pseudo-obstruction
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Mesenteric arterial occlusion
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
2.0%
4/200 • Number of events 4 • 5 years
|
|
Gastrointestinal disorders
Pancreatic disorder
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Pancreatitis acute
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Volvulus
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
4/200 • Number of events 4 • 5 years
|
|
General disorders
Asthenia
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
General disorders
Chest pain
|
3.5%
7/200 • Number of events 12 • 5 years
|
|
General disorders
Fatigue
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
General disorders
Impaired healing
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
General disorders
Malaise
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
General disorders
Non-cardiac chest pain
|
2.5%
5/200 • Number of events 6 • 5 years
|
|
General disorders
Pain
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
General disorders
Physical deconditioning
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
General disorders
Pyrexia
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
General disorders
Stent-graft endoleak
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
General disorders
Vascular stent stenosis
|
2.0%
4/200 • Number of events 4 • 5 years
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Hepatobiliary disorders
Cholecystitis acute
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Hepatobiliary disorders
Gallbladder polyp
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Hepatobiliary disorders
Hepatic mass
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Hepatobiliary disorders
Portal hypertension
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Immune system disorders
Hypersensitivity
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Infections and infestations
Abscess limb
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Infections and infestations
Bacteraemia
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Infections and infestations
Bacterial colitis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Infections and infestations
Bronchitis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Infections and infestations
Cellulitis
|
3.0%
6/200 • Number of events 6 • 5 years
|
|
Infections and infestations
Cellulitis streptococcal
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Infections and infestations
Device related infection
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Infections and infestations
Device related sepsis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Infections and infestations
Diverticulitis
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Infections and infestations
Emphysematous cholecystitis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Infections and infestations
Empyema
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Infections and infestations
Endocarditis
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Infections and infestations
Endocarditis bacterial
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Infections and infestations
Gangrene
|
2.5%
5/200 • Number of events 8 • 5 years
|
|
Infections and infestations
Gastroenteritis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Infections and infestations
Incision site cellulitis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Infections and infestations
Infection
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Infections and infestations
Intervertebral discitis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Infections and infestations
Large intestine infection
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Infections and infestations
Meningitis bacterial
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Infections and infestations
Osteomyelitis
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Infections and infestations
Parotitis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Infections and infestations
Peritonitis
|
0.50%
1/200 • Number of events 3 • 5 years
|
|
Infections and infestations
Pneumonia
|
9.5%
19/200 • Number of events 25 • 5 years
|
|
Infections and infestations
Postoperative wound infection
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.50%
1/200 • Number of events 3 • 5 years
|
|
Infections and infestations
Pyelonephritis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Infections and infestations
Sepsis
|
2.5%
5/200 • Number of events 5 • 5 years
|
|
Infections and infestations
Sinusitis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Infections and infestations
Staphylococcal bacteraemia
|
1.5%
3/200 • Number of events 3 • 5 years
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Infections and infestations
Urinary tract infection
|
5.0%
10/200 • Number of events 12 • 5 years
|
|
Infections and infestations
Vascular access site infection
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Infections and infestations
West Nile viral infection
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Infections and infestations
Wound infection
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Abdominal wound dehiscence
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Arterial bypass occlusion
|
1.0%
2/200 • Number of events 3 • 5 years
|
|
Injury, poisoning and procedural complications
Arterial bypass stenosis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Arterial bypass thrombosis
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Injury, poisoning and procedural complications
Arterial restenosis
|
1.5%
3/200 • Number of events 3 • 5 years
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.50%
1/200 • Number of events 2 • 5 years
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site haematoma
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula thrombosis
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Injury, poisoning and procedural complications
Arteriovenous graft thrombosis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Cardiac valve rupture
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Carotid artery restenosis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Contusion
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
4.0%
8/200 • Number of events 11 • 5 years
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.50%
1/200 • Number of events 2 • 5 years
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
19.5%
39/200 • Number of events 60 • 5 years
|
|
Injury, poisoning and procedural complications
Periprosthetic fracture
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Post procedural bile leak
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Postoperative respiratory distress
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.50%
1/200 • Number of events 2 • 5 years
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Restenosis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Seroma
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.0%
2/200 • Number of events 3 • 5 years
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.50%
1/200 • Number of events 2 • 5 years
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.50%
1/200 • Number of events 2 • 5 years
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Vascular graft stenosis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Investigations
Catheterisation cardiac abnormal
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Investigations
International normalised ratio increased
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Investigations
Troponin
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Investigations
White blood cell count increased
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
1.5%
3/200 • Number of events 3 • 5 years
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
1.5%
3/200 • Number of events 3 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Joint contracture
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.5%
3/200 • Number of events 4 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Osteochondrosis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Spinal synovial cyst
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer recurrent
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal papillary mucinous neoplasm
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma recurrent
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer metastatic
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified stage IV
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant respiratory tract neoplasm
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lung
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
1.5%
3/200 • Number of events 3 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
1.5%
3/200 • Number of events 3 • 5 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Throat cancer
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Nervous system disorders
Carotid artery stenosis
|
2.0%
4/200 • Number of events 6 • 5 years
|
|
Nervous system disorders
Cerebrovascular accident
|
4.5%
9/200 • Number of events 9 • 5 years
|
|
Nervous system disorders
Dizziness
|
1.5%
3/200 • Number of events 3 • 5 years
|
|
Nervous system disorders
Encephalopathy
|
1.5%
3/200 • Number of events 3 • 5 years
|
|
Nervous system disorders
Headache
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Nervous system disorders
Lethargy
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Nervous system disorders
Loss of consciousness
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Nervous system disorders
Myoclonus
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Nervous system disorders
Neuropathy peripheral
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Nervous system disorders
Presyncope
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Nervous system disorders
Sciatica
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Nervous system disorders
Spinal cord compression
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Nervous system disorders
Syncope
|
3.0%
6/200 • Number of events 6 • 5 years
|
|
Nervous system disorders
Toxic encephalopathy
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Nervous system disorders
Transient ischaemic attack
|
2.0%
4/200 • Number of events 4 • 5 years
|
|
Product Issues
Device damage
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Depression
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Psychiatric disorders
Mental status changes
|
1.5%
3/200 • Number of events 3 • 5 years
|
|
Psychiatric disorders
Substance abuse
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Acute kidney injury
|
3.5%
7/200 • Number of events 9 • 5 years
|
|
Renal and urinary disorders
Bladder mass
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
End stage renal disease
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Haematuria
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Hydronephrosis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Renal and urinary disorders
Renal artery stenosis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Renal and urinary disorders
Renal failure
|
5.0%
10/200 • Number of events 12 • 5 years
|
|
Renal and urinary disorders
Urinary retention
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Reproductive system and breast disorders
Cystocele
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Reproductive system and breast disorders
Penis disorder
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.5%
5/200 • Number of events 5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
4.0%
8/200 • Number of events 10 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
4/200 • Number of events 4 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Obliterative bronchiolitis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.5%
7/200 • Number of events 9 • 5 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Skin and subcutaneous tissue disorders
Ischaemic skin ulcer
|
4.0%
8/200 • Number of events 16 • 5 years
|
|
Surgical and medical procedures
Debridement
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
Dialysis device insertion
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
Medical device battery replacement
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
Medical device removal
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
Mitral valve repair
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Surgical and medical procedures
Rotator cuff repair
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Vascular disorders
Aortic aneurysm
|
1.5%
3/200 • Number of events 3 • 5 years
|
|
Vascular disorders
Aortic stenosis
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Vascular disorders
Arterial stenosis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Vascular disorders
Atheroembolism
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Vascular disorders
Deep vein thrombosis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Vascular disorders
Haematoma
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Vascular disorders
Hypertension
|
1.0%
2/200 • Number of events 3 • 5 years
|
|
Vascular disorders
Hypertensive emergency
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Vascular disorders
Hypotension
|
1.5%
3/200 • Number of events 3 • 5 years
|
|
Vascular disorders
Hypovolaemic shock
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Vascular disorders
Intermittent claudication
|
16.0%
32/200 • Number of events 48 • 5 years
|
|
Vascular disorders
Ischaemia
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Vascular disorders
Orthostatic hypotension
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Vascular disorders
Peripheral artery dissection
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Vascular disorders
Peripheral artery occlusion
|
8.5%
17/200 • Number of events 22 • 5 years
|
|
Vascular disorders
Peripheral artery stenosis
|
2.0%
4/200 • Number of events 4 • 5 years
|
|
Vascular disorders
Peripheral artery thrombosis
|
5.0%
10/200 • Number of events 19 • 5 years
|
|
Vascular disorders
Peripheral coldness
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Vascular disorders
Peripheral embolism
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Vascular disorders
Peripheral ischaemia
|
1.0%
2/200 • Number of events 3 • 5 years
|
|
Vascular disorders
Peripheral vascular disorder
|
1.0%
2/200 • Number of events 3 • 5 years
|
|
Vascular disorders
Steal syndrome
|
1.0%
2/200 • Number of events 2 • 5 years
|
|
Vascular disorders
Subclavian artery stenosis
|
0.50%
1/200 • Number of events 1 • 5 years
|
|
Vascular disorders
Thrombophlebitis
|
0.50%
1/200 • Number of events 1 • 5 years
|
Other adverse events
| Measure |
Drug-Eluting Stent
n=200 participants at risk
Zilver® PTX® Drug-Eluting Peripheral Stent: Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
|
|---|---|
|
Injury, poisoning and procedural complications
Peripheral artery restenosis
|
8.0%
16/200 • Number of events 16 • 5 years
|
|
Vascular disorders
Intermittent claudication
|
16.0%
32/200 • Number of events 45 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications from PI prior to public release and can embargo communications of trial results between 60 and 180 days from the time submitted to the sponsor for review. The sponsor can embargo publications until the sponsor has published results or 180 days has elapsed after study closure at all participating sites. The sponsor cannot restrict publication but can require changes to protect sponsor's intellectual property rights or other confidential information.
- Publication restrictions are in place
Restriction type: OTHER