Trial Outcomes & Findings for Evaluation of the GORE TIGRIS Vascular Stent (NCT NCT01576055)

NCT ID: NCT01576055

Last Updated: 2017-10-09

Results Overview

Defined as any adverse event (occurring within 30 days of the initial procedure) that causes death, target vessel revascularization (TVR), and amputation above the metatarsals in the treated leg (index limb amputation).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 267 participants
• Primary outcome timeframe: 30 Days
• Results posted on: 2017-10-09

Participant Flow

Participant milestones

Measure	TIGRIS Vascular Stent TIGRIS Vascular Stent: Implant	BARD LifeStent BARD LifeStent: Implant
Overall Study STARTED	197	70
Overall Study COMPLETED	178	64
Overall Study NOT COMPLETED	19	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the GORE TIGRIS Vascular Stent

Baseline characteristics by cohort

Measure	TIGRIS Vascular Stent n=197 Participants TIGRIS Vascular Stent: Implant	BARD LifeStent n=70 Participants BARD LifeStent: Implant	Total n=267 Participants Total of all reporting groups
Age, Continuous	66.8 years STANDARD_DEVIATION 9.30 • n=5 Participants	67.9 years STANDARD_DEVIATION 8.87 • n=7 Participants	67.0 years STANDARD_DEVIATION 9.17 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	21 Participants n=7 Participants	77 Participants n=5 Participants
Sex: Female, Male Male	141 Participants n=5 Participants	49 Participants n=7 Participants	190 Participants n=5 Participants
Region of Enrollment United States	142 participants n=5 Participants	54 participants n=7 Participants	196 participants n=5 Participants
Region of Enrollment Europe	55 participants n=5 Participants	16 participants n=7 Participants	71 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 Days

Population: Per Protocol Population (Participants Available for 30-Day Follow-Up)

Defined as any adverse event (occurring within 30 days of the initial procedure) that causes death, target vessel revascularization (TVR), and amputation above the metatarsals in the treated leg (index limb amputation).

Outcome measures

Measure	TIGRIS Vascular Stent n=188 Participants TIGRIS Vascular Stent: Implant	BARD LifeStent n=69 Participants BARD LifeStent: Implant
Primary Safety Endpoint - Number of Participants Free From Major Adverse Events at 30 Days	187 participants	69 participants

PRIMARY outcome

Timeframe: 12 Months

Population: Per Protocol Population (Participants Available for 12-Month Follow-Up)

Primary patency is defined by a Peak Systolic Velocity Ratio (PSVR) ≤2.5 without target lesion revascularization (TLR) at 12 months after implantation.

Outcome measures

Measure	TIGRIS Vascular Stent n=170 Participants TIGRIS Vascular Stent: Implant	BARD LifeStent n=64 Participants BARD LifeStent: Implant
Primary Efficacy Endpoint - Number of Participants With Primary Patency at 12 Months	97 participants	35 participants

SECONDARY outcome

Timeframe: Within 48 hours of initial device implant

Population: Per Protocol Population

Successful device implantation with a residual stenosis <30% without acute (within 48 hours) serious adverse events.

Outcome measures

Measure	TIGRIS Vascular Stent n=197 Participants TIGRIS Vascular Stent: Implant	BARD LifeStent n=70 Participants BARD LifeStent: Implant
Number of Participants With Procedural Success	196 participants	68 participants

SECONDARY outcome

Timeframe: Immediately following initial device implant (usually within a few minutes to an hour).

Population: Per Protocol Population

Successful delivery of stent to the intended site and successful stent deployment.

Outcome measures

Measure	TIGRIS Vascular Stent n=197 Participants TIGRIS Vascular Stent: Implant	BARD LifeStent n=70 Participants BARD LifeStent: Implant
Number of Participants With Device Success	196 participants	70 participants

Adverse Events

TIGRIS Vascular Stent

Serious events: 102 serious events

Other events: 46 other events

Deaths: 0 deaths

BARD LifeStent

Serious events: 34 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Measure	TIGRIS Vascular Stent n=197 participants at risk TIGRIS Vascular Stent: Implant	BARD LifeStent n=70 participants at risk BARD LifeStent: Implant
Blood and lymphatic system disorders Anaemia	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Blood and lymphatic system disorders Anaemia of chronic disease	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Blood and lymphatic system disorders Iron deficiency anaemia	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Cardiac disorders Acute coronary syndrome	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Cardiac disorders Acute myocardial infarction	2.5% 5/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	2.9% 2/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Cardiac disorders Angina pectoris	2.5% 5/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	2.9% 2/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Cardiac disorders Angina unstable	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Cardiac disorders Atrial fibrillation	2.0% 4/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Cardiac disorders Cardiac arrest	1.5% 3/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Cardiac disorders Cardiac failure	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Cardiac disorders Cardiac failure acute	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Cardiac disorders Cardiac failure chronic	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Cardiac disorders Cardiac failure congestive	1.5% 3/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	4.3% 3/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Cardiac disorders Coronary artery disease	2.0% 4/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Cardiac disorders Coronary artery stenosis	1.0% 2/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Cardiac disorders Myocardial infarction	2.0% 4/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Cardiac disorders Tachycardia	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Cardiac disorders Ventricular fibrillation	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Eye disorders Retinal artery embolism	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Eye disorders Retinal detachment	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Gastrointestinal disorders Abdominal pain	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Gastrointestinal disorders Colitis ischaemic	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Gastrointestinal disorders Diaphragmatic hernia	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Gastrointestinal disorders Diarrhoea	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Gastrointestinal disorders Gastric ulcer	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Gastrointestinal disorders Gastrointestinal haemorrhage	1.5% 3/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Gastrointestinal disorders Gastrointestinal necrosis	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Gastrointestinal disorders Intestinal ischaemia	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Gastrointestinal disorders Intestinal mass	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Gastrointestinal disorders Large intestinal obstruction	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Gastrointestinal disorders Melaena	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Gastrointestinal disorders Small intestinal obstruction	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
General disorders Adverse drug reaction	1.0% 2/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
General disorders Asthenia	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
General disorders Device breakage	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
General disorders Device dislocation	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
General disorders Device occlusion	1.5% 3/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
General disorders Medical device complication	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
General disorders Medical device entrapment	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
General disorders Non-cardiac chest pain	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
General disorders Oedema peripheral	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
General disorders Vascular stent restenosis	12.2% 24/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	12.9% 9/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
General disorders Vascular stent thrombosis	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
General disorders Vessel puncture site haematoma	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
General disorders Vessel puncture site haemorrhage	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Hepatobiliary disorders Hepatic failure	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Infections and infestations Abdominal abscess	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Infections and infestations Cellulitis	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Infections and infestations Device related infection	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Infections and infestations Diverticulitis	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Infections and infestations Diverticulitis intestinal haemorrhagic	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Infections and infestations Erysipelas	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Infections and infestations Escherichia bacteraemia	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Infections and infestations Gangrene	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Infections and infestations Gastroenteritis	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Infections and infestations Gastroenteritis viral	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Infections and infestations Localised infection	1.0% 2/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Infections and infestations Pneumonia	1.0% 2/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	2.9% 2/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Infections and infestations Postoperative wound infection	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Infections and infestations Pulmonary sepsis	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Infections and infestations Sepsis	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Infections and infestations Septic shock	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Infections and infestations Subcutaneous abscess	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Infections and infestations Urinary tract infection	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Infections and infestations Urosepsis	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Infections and infestations Wound infection	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Injury, poisoning and procedural complications Anaemia postoperative	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Injury, poisoning and procedural complications Arterial restenosis	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Injury, poisoning and procedural complications Femur fracture	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Injury, poisoning and procedural complications Hip fracture	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Injury, poisoning and procedural complications Ligament sprain	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Injury, poisoning and procedural complications Peripheral artery restenosis	1.0% 2/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Injury, poisoning and procedural complications Post procedural complication	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Injury, poisoning and procedural complications Post procedural myocardial infarction	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Injury, poisoning and procedural complications Prescribed overdose	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Injury, poisoning and procedural complications Procedural complication	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Injury, poisoning and procedural complications Tendon rupture	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Injury, poisoning and procedural complications Vascular graft occlusion	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Injury, poisoning and procedural complications Vascular graft thrombosis	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Injury, poisoning and procedural complications Vascular pseudoaneurysm	3.0% 6/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Injury, poisoning and procedural complications Wrist fracture	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Metabolism and nutrition disorders Acidosis	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Metabolism and nutrition disorders Diabetes mellitus inadequate control	1.0% 2/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Metabolism and nutrition disorders Diabetic ketoacidosis	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Metabolism and nutrition disorders Hyperglycaemia	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Metabolism and nutrition disorders Hypoglycaemia	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Musculoskeletal and connective tissue disorders Arthralgia	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Musculoskeletal and connective tissue disorders Neuropathic arthropathy	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Musculoskeletal and connective tissue disorders Osteoarthritis	2.0% 4/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung adenocarcinoma stage IV	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Renal cancer metastatic	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell carcinoma	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small cell lung cancer	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Nervous system disorders Brain stem ischaemia	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Nervous system disorders Carotid artery stenosis	1.5% 3/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Nervous system disorders Cerebral infarction	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Nervous system disorders Cerebrovascular accident	1.0% 2/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	2.9% 2/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Nervous system disorders Embolic stroke	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Nervous system disorders Haemorrhagic stroke	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Nervous system disorders Ischaemic stroke	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Nervous system disorders Metabolic encephalopathy	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Nervous system disorders Syncope	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Nervous system disorders Transient ischaemic attack	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Renal and urinary disorders Acute kidney injury	2.5% 5/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Renal and urinary disorders Chronic kidney disease	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Renal and urinary disorders Renal failure	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Renal and urinary disorders Renal tubular necrosis	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.0% 2/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	2.9% 2/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Respiratory, thoracic and mediastinal disorders Pneumothorax spontaneous	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	1.0% 2/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Vascular disorders Aortic aneurysm	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Vascular disorders Femoral artery dissection	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Vascular disorders Femoral artery occlusion	1.0% 2/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Vascular disorders Hypertensive crisis	1.0% 2/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Vascular disorders Hypertensive emergency	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Vascular disorders Hypotension	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Vascular disorders Intermittent claudication	3.0% 6/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	4.3% 3/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Vascular disorders Peripheral arterial occlusive disease	2.0% 4/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	2.9% 2/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Vascular disorders Peripheral artery aneurysm	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Vascular disorders Peripheral artery stenosis	8.1% 16/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Vascular disorders Peripheral ischaemia	0.00% 0/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Vascular disorders Peripheral vascular disorder	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	1.4% 1/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Vascular disorders Vessel perforation	0.51% 1/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	0.00% 0/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).

Other adverse events

Measure	TIGRIS Vascular Stent n=197 participants at risk TIGRIS Vascular Stent: Implant	BARD LifeStent n=70 participants at risk BARD LifeStent: Implant
General disorders Vascular stent restenosis	11.2% 22/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	8.6% 6/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Vascular disorders Intermittent claudication	11.2% 22/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	12.9% 9/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).
Vascular disorders Peripheral artery stenosis	5.6% 11/197 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).	10.0% 7/70 • Adverse events were collected from the study initiation to submission (approximately 3 years, 4 months).

Additional Information

Thomas Sabin

W.L. Gore & Associates

Phone: 928-864-3153

Email: tsabin@wlgore.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60