Trial Outcomes & Findings for Renal Stent Placement for the Treatment of Renal Artery Stenosis in Patients With Resistant Hypertension (NCT NCT01673373)

Last Updated: 2020-11-20

Results Overview

Primary patency rate at 9 months was defined as continuous patency without the occurrence of a total occlusion of the original lesion, without a re-intervention to treat a partial or total occlusion of the stented segment, or bypass of the stented segment due to clinically-driven restenosis or occlusion.

Recruitment status

COMPLETED

Study phase

Target enrollment

68 participants

Primary outcome timeframe

9 months

Results posted on

2020-11-20

Participant Flow

Participant milestones

Participant milestones
Measure	iCAST™ RX Stent System All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Overall Study STARTED	68
Overall Study COMPLETED	66
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	iCAST™ RX Stent System All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Overall Study Death	2

Baseline Characteristics

Renal Stent Placement for the Treatment of Renal Artery Stenosis in Patients With Resistant Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	iCAST™ RX Stent System n=68 Participants All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants
Age, Categorical >=65 years	52 Participants n=5 Participants
Age, Continuous	71.7 years STANDARD_DEVIATION 10.17 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	68 Participants n=5 Participants
Number of Qualifying Lesions Unilateral	54 Participants n=5 Participants
Number of Qualifying Lesions Bilateral	14 Participants n=5 Participants
Systolic Blood Pressure	166.2 mmHg STANDARD_DEVIATION 12.19 • n=5 Participants

PRIMARY outcome

Timeframe: 9 months

Population: Subset of enrolled subjects with available duplex ultrasound or angiography assessment within the 9-month visit window.

Outcome measures

Outcome measures
Measure	iCAST™ RX Stent System n=70 Subject-lesions All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Primary Patency	66 Subject-lesions

PRIMARY outcome

Timeframe: Baseline and 9 months

Population: Subset of enrolled subjects with available blood pressure data at baseline and 9 months.

Change in systolic blood pressure (SBP) at 9 months as compared to baseline SBP.

Outcome measures

Outcome measures
Measure	iCAST™ RX Stent System n=63 Participants All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Systolic Blood Pressure	15.7 mmHg Standard Deviation 21.20

SECONDARY outcome

Timeframe: 30 days, 9 months

Population: All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.

The occurence of procedure-related MAEs is reported as a percentage of subjects with MAE. Inclusive of: 1. Procedure- or device-related occurrence of death 2. Q-Wave myocardial infarction (MI) 3. Clinically driven target lesion revascularization (TLR) 4. Significant embolic events defined as unanticipated kidney/bowel infarct, clinically driven by symptoms of abdominal or back pain and confirmed with CT scan or open surgery; lower extremity ulceration or gangrene; or kidney failure.

Outcome measures

Outcome measures
Measure	iCAST™ RX Stent System n=68 Participants All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Procedure-Related Major Adverse Events (MAE) Overall subjects experiencing MAE	5 Participants
Procedure-Related Major Adverse Events (MAE) MAE within 30 days	0 Participants
Procedure-Related Major Adverse Events (MAE) MAE within 9 months	2 Participants

SECONDARY outcome

Timeframe: Day of Procedure

Population: All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion with available angiography.

Technical success is defined as successful delivery and deployment of the iCAST™ RX Stent System with ≤ 30% residual angiographic stenosis after covered stent deployment (including post-dilatation) assessed via quantitative vascular analysis (QVA) by an independent core laboratory.

Outcome measures

Outcome measures
Measure	iCAST™ RX Stent System n=81 Subject-lesions All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Technical Success	81 Subject-lesions

SECONDARY outcome

Timeframe: Day of Procedure, prior to hospital discharge

Acute procedural success is defined as technical success without the occurrence of MAE prior to hospital discharge.

Outcome measures

Outcome measures
Measure	iCAST™ RX Stent System n=81 Subject-lesions All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Acute Procedural Success	81 Subject-lesions

SECONDARY outcome

Timeframe: 9 months

Population: All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion.

Target Lesion Revascularization (TLR) is measured as the proportion of subjects-lesions that require a clinically-driven reintervention of the target lesion through 9 months. a. A clinically-driven TLR is defined as a TLR (percutaneous balloon angioplasty (PTA), bare metal stent or repeat covered stent deployment, or surgical bypass) due to documented recurrent hypertension from 30-days post-procedure level and/or deterioration in renal function from baseline value, associated with angiographic core laboratory adjudication of a ≥ 60% diameter covered stent restenosis.

Outcome measures

Outcome measures
Measure	iCAST™ RX Stent System n=82 Subject-lesions All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Target Lesion Revascularization (TLR)	3 Subject-lesions

SECONDARY outcome

Timeframe: 9 months

Population: All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion.

The rate of incidental TLR is the rate of TLRs not meeting the definition of a clinically-driven TLR.

Outcome measures

Outcome measures
Measure	iCAST™ RX Stent System n=82 Subject-lesions All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Rate of Incidental TLR	2 Subject-lesions

SECONDARY outcome

Timeframe: Baseline and 30 days

Population: Subset of enrolled subjects with available blood pressure measurements at both time points.

The change in SBP from baseline to 30 days

Outcome measures

Outcome measures
Measure	iCAST™ RX Stent System n=67 Participants All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Systolic Blood Pressure (SBP) Control	-13.6 mmHg Standard Deviation 18.83

SECONDARY outcome

Timeframe: Baseline and 9 months

Population: Subset of enrolled subjects with available blood pressure measurements at both time points.

The change in SBP from baseline to 9 months

Outcome measures

Outcome measures
Measure	iCAST™ RX Stent System n=63 Participants All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
SBP Control	-15.7 mmHg Standard Deviation 21.20

SECONDARY outcome

Timeframe: 9 months

Population: All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System. Note that analysis is per subject lesion.

Secondary patency rate at 9 months after a clinically-driven TLR which restores patency after total occlusion.

Outcome measures

Outcome measures
Measure	iCAST™ RX Stent System n=82 Subject-lesions All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Secondary Patency Rate	3 Subject-lesions

SECONDARY outcome

Timeframe: Baseline and 9 months

Population: Subset of enrolled subjects with available medication information.

Change in number of anti-hypertensive medications as compared to baseline.

Outcome measures

Outcome measures
Measure	iCAST™ RX Stent System n=63 Participants All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Change in Number of Anti-Hypertensive Medications	-0.1 Number of Anti-hypertensive Medications Standard Deviation 0.76

SECONDARY outcome

Timeframe: Baseline and 30 days

Population: Subset of enrolled subjects with available eGFR measurements.

Renal function compared to baseline as measured by estimated Glomerular Filtration Rate (eGFR) at 30 days.

Outcome measures

Outcome measures
Measure	iCAST™ RX Stent System n=67 Participants All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Change in Renal Function	-0.5520 eGFR mL/min/1.73 m^2 Standard Deviation 8.42795

SECONDARY outcome

Timeframe: Baseline and 9 months

Population: Subset of enrolled subjects with available eGFR measurements.

Renal function compared to baseline as measured by estimated Glomerular Filtration Rate (eGFR) at 9 months.

Outcome measures

Outcome measures
Measure	iCAST™ RX Stent System n=65 Participants All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Change in Renal Function	-1.9964 eGFR mL/min/1.73 m^2 Standard Deviation 13.42781

Adverse Events

iCAST™ RX Stent System

Serious events: 40 serious events

Other events: 12 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	iCAST™ RX Stent System n=68 participants at risk All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Blood and lymphatic system disorders Anaemia	4.4% 3/68 • Number of events 3 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Blood and lymphatic system disorders Iron deficiency anaemia	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Blood and lymphatic system disorders Normochromic normocytic anaemia	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Cardiac disorders Angina pectoris	10.3% 7/68 • Number of events 7 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Cardiac disorders Arrhythmia	7.4% 5/68 • Number of events 5 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Cardiac disorders Atrial fibrillation	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Cardiac disorders Bradycardia	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Cardiac disorders Cardiac arrest	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Cardiac disorders Cardiac failure congestive	8.8% 6/68 • Number of events 6 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Cardiac disorders Cardiomyopathy	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Cardiac disorders Coronary artery stenosis	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Cardiac disorders Myocardial infarction	2.9% 2/68 • Number of events 2 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Cardiac disorders Pericardial effusion	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Endocrine disorders Adrenal insufficiency	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Gastrointestinal disorders Diarrhoea	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Gastrointestinal disorders Gastrointestinal necrosis	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Gastrointestinal disorders Mesenteric artery stenosis	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Gastrointestinal disorders Oesophageal spasm	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Gastrointestinal disorders Pancreatitis	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Gastrointestinal disorders Small intestinal obstruction	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
General disorders Chest pain	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
General disorders Device occlusion	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
General disorders Non-cardiac chest pain	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Infections and infestations Appendicitis	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Infections and infestations Bronchitis	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Infections and infestations Gastroenteritis	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Infections and infestations Pneumonia	8.8% 6/68 • Number of events 6 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Infections and infestations Urinary tract infection	2.9% 2/68 • Number of events 2 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Injury, poisoning and procedural complications Arterial restenosis	11.8% 8/68 • Number of events 9 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Injury, poisoning and procedural complications Concussion	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Injury, poisoning and procedural complications Fall	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Injury, poisoning and procedural complications Hip fracture	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Injury, poisoning and procedural complications Spinal compression fracture	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Metabolism and nutrition disorders Dehydration	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin cancer	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Nervous system disorders Carotid artery stenosis	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Nervous system disorders Cerebrovascular accident	5.9% 4/68 • Number of events 4 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Psychiatric disorders Depression	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Renal and urinary disorders Glomerulonephritis	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Renal and urinary disorders Hydronephrosis	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Renal and urinary disorders Nephrolithiasis	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Renal and urinary disorders Renal failure acute	2.9% 2/68 • Number of events 2 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	1.5% 1/68 • Number of events 5 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Skin and subcutaneous tissue disorders Skin ulcer	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Vascular disorders Brachiocephalic artery occlusion	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Vascular disorders Hypertension	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Vascular disorders Hypertensive emergency	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Vascular disorders Hypovolaemic shock	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Vascular disorders Iliac artery stenosis	2.9% 2/68 • Number of events 2 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Vascular disorders Intermittent claudication	2.9% 2/68 • Number of events 2 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Vascular disorders Malignant hypertension	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Vascular disorders Peripheral arterial occlusive disease	2.9% 2/68 • Number of events 2 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Vascular disorders Peripheral vascular disorder	2.9% 2/68 • Number of events 2 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Vascular disorders Subclavian artery aneurysm	1.5% 1/68 • Number of events 1 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.

Other adverse events

Other adverse events
Measure	iCAST™ RX Stent System n=68 participants at risk All enrolled subjects, defined as patients that underwent primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
Blood and lymphatic system disorders Anaemia	5.9% 4/68 • Number of events 4 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Injury, poisoning and procedural complications Subcutaneous haematoma	5.9% 4/68 • Number of events 4 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.4% 5/68 • Number of events 6 • Non-serious Adverse Events were reported through 9 months. Serious Adverse Events were reported through 3 years. Note that the adverse events reported are those reported through the cut off date related to the primary endpoint analysis.

Additional Information

Sr. Clinical Trial Manager

Getinge

Phone: 603-864-5219

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place