Trial Outcomes & Findings for TORUS I Clinical Study (NCT NCT03128424)

NCT ID: NCT03128424

Last Updated: 2025-10-29

Results Overview

Freedom from a MAE as defined as target lesion revascularization (TLR), amputation of the treated limb or death.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2025-10-29

Participant Flow

Participant milestones

Measure	PQ Bypass Stent Graft System The PQ Bypass™ Stent Graft System is intended for patients with atherosclerotic lesions of the SFA PQ Bypass Stent Graft System: The PQ Bypass™ Stent Graft System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery, with reference vessel diameters of 5.0 to 6.7 mm and lesion lengths up to 180 mm.
Overall Study STARTED	60
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	PQ Bypass Stent Graft System n=60 Participants The PQ Bypass™ Stent Graft System is intended for patients with atherosclerotic lesions of the SFA PQ Bypass Stent Graft System: The PQ Bypass™ Stent Graft System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery, with reference vessel diameters of 5.0 to 6.7 mm and lesion lengths up to 180 mm.
Age, Continuous	66.5 years STANDARD_DEVIATION 8.6 • n=60 Participants
Sex: Female, Male Female	9 Participants n=60 Participants
Sex: Female, Male Male	51 Participants n=60 Participants
Region of Enrollment Germany	30 participants n=60 Participants
Region of Enrollment Austria	1 participants n=60 Participants
Region of Enrollment Latvia	20 participants n=60 Participants
Region of Enrollment Poland	9 participants n=60 Participants

PRIMARY outcome

Timeframe: 30 days

Freedom from a MAE as defined as target lesion revascularization (TLR), amputation of the treated limb or death.

Outcome measures

Measure

PQ Bypass Stent Graft System n=60 Participants The PQ Bypass™ Stent Graft System is intended for patients with atherosclerotic lesions of the SFA PQ Bypass Stent Graft System: The PQ Bypass™ Stent Graft System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery, with reference vessel diameters of 5.0 to 6.7 mm and lesion lengths up to 180 mm.

Number of Participants With Freedom From a Major Adverse Event (MAE)

60 Participants

PRIMARY outcome

Timeframe: 12 Month

Population: Through 12 months, 50 subjects provided data on both PSVR and clinically driven re-intervention. Subjects with Absolute peak systolic velocity (PSV) numbers and no PSVR ratio were included in the primary patency assessment.

The primary effectiveness endpoint is defined as stent patency as evidenced by a peak systolic velocity ratio (PSVR) < 2.5 from DUS obtained within the 12- month visit window with no clinically driven re-intervention within the stented segment

Outcome measures

Measure

PQ Bypass Stent Graft System n=50 Participants The PQ Bypass™ Stent Graft System is intended for patients with atherosclerotic lesions of the SFA PQ Bypass Stent Graft System: The PQ Bypass™ Stent Graft System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery, with reference vessel diameters of 5.0 to 6.7 mm and lesion lengths up to 180 mm.

Primary Effectiveness

38 Participants

SECONDARY outcome

Timeframe: Procedure

Acute technical successdefined as : successful delivery, access and placement of the investigation devies and successful removal of the delivery system

Outcome measures

Measure

PQ Bypass Stent Graft System n=60 Participants The PQ Bypass™ Stent Graft System is intended for patients with atherosclerotic lesions of the SFA PQ Bypass Stent Graft System: The PQ Bypass™ Stent Graft System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery, with reference vessel diameters of 5.0 to 6.7 mm and lesion lengths up to 180 mm.

Technical Success

60 Participants

SECONDARY outcome

Timeframe: 12 months

Clinically Driven Target Lesion Revascularization (CD-TLR)

Outcome measures

Measure	PQ Bypass Stent Graft System n=60 Participants The PQ Bypass™ Stent Graft System is intended for patients with atherosclerotic lesions of the SFA PQ Bypass Stent Graft System: The PQ Bypass™ Stent Graft System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery, with reference vessel diameters of 5.0 to 6.7 mm and lesion lengths up to 180 mm.
Lesion Success 12 months Rate of CD-TLR	4 Participants
Lesion Success 12 Month Freedom from CD-TLR	56 Participants

SECONDARY outcome

Timeframe: 6 months

A Major Adverse Event (MAE) is defined as all cause mortality, target limb major amputation, and clinically driven target lesion revascularization (CD-TLR).

Outcome measures

Measure

PQ Bypass Stent Graft System n=60 Participants The PQ Bypass™ Stent Graft System is intended for patients with atherosclerotic lesions of the SFA PQ Bypass Stent Graft System: The PQ Bypass™ Stent Graft System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery, with reference vessel diameters of 5.0 to 6.7 mm and lesion lengths up to 180 mm.

Major Adverse Event (MAE) 6 Month

1 Participants

SECONDARY outcome

Timeframe: 12 month

An MAE is defined as target lesion revascularization (TLR), amputation of the treated limb or death.

Outcome measures

Measure

PQ Bypass Stent Graft System n=60 Participants The PQ Bypass™ Stent Graft System is intended for patients with atherosclerotic lesions of the SFA PQ Bypass Stent Graft System: The PQ Bypass™ Stent Graft System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery, with reference vessel diameters of 5.0 to 6.7 mm and lesion lengths up to 180 mm.

Major Adverse Event (MAE) 12 Months

5 Participants

SECONDARY outcome

Timeframe: 12 Month

Stent Fracture, Migration, and Separation

Outcome measures

Measure

PQ Bypass Stent Graft System n=60 Participants The PQ Bypass™ Stent Graft System is intended for patients with atherosclerotic lesions of the SFA PQ Bypass Stent Graft System: The PQ Bypass™ Stent Graft System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery, with reference vessel diameters of 5.0 to 6.7 mm and lesion lengths up to 180 mm.

TORUS Stent Fracture, Migration, and Separation

0 Participants

Adverse Events

PQ Bypass Stent Graft System

Serious events: 31 serious events

Other events: 30 other events

Deaths: 2 deaths

Serious adverse events

Measure	PQ Bypass Stent Graft System n=60 participants at risk The PQ Bypass™ Stent Graft System is intended for patients with atherosclerotic lesions of the SFA PQ Bypass Stent Graft System: The PQ Bypass™ Stent Graft System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery, with reference vessel diameters of 5.0 to 6.7 mm and lesion lengths up to 180 mm.
Gastrointestinal disorders Gastrointestinal disorders	6.7% 4/60 • 24 Months Adverse events were reviewed by an independent Medical Monitor. MedDRA Lower-Level Terms (LLTs) were assigned by a certified MedDRA coder. The LLTs were mapped to their corresponding Preferred Terms (PTs) and System Organ Categories (SOCs).
General disorders General disorders and administration site conditions	40.0% 24/60 • 24 Months Adverse events were reviewed by an independent Medical Monitor. MedDRA Lower-Level Terms (LLTs) were assigned by a certified MedDRA coder. The LLTs were mapped to their corresponding Preferred Terms (PTs) and System Organ Categories (SOCs).
Immune system disorders Immune system disorders	1.7% 1/60 • 24 Months Adverse events were reviewed by an independent Medical Monitor. MedDRA Lower-Level Terms (LLTs) were assigned by a certified MedDRA coder. The LLTs were mapped to their corresponding Preferred Terms (PTs) and System Organ Categories (SOCs).
Infections and infestations Infections and infestations	3.3% 2/60 • 24 Months Adverse events were reviewed by an independent Medical Monitor. MedDRA Lower-Level Terms (LLTs) were assigned by a certified MedDRA coder. The LLTs were mapped to their corresponding Preferred Terms (PTs) and System Organ Categories (SOCs).
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	1.7% 1/60 • 24 Months Adverse events were reviewed by an independent Medical Monitor. MedDRA Lower-Level Terms (LLTs) were assigned by a certified MedDRA coder. The LLTs were mapped to their corresponding Preferred Terms (PTs) and System Organ Categories (SOCs).
Metabolism and nutrition disorders Metabolism and nutrition disorders	1.7% 1/60 • 24 Months Adverse events were reviewed by an independent Medical Monitor. MedDRA Lower-Level Terms (LLTs) were assigned by a certified MedDRA coder. The LLTs were mapped to their corresponding Preferred Terms (PTs) and System Organ Categories (SOCs).
Cardiac disorders Cardiac disorders	10.0% 6/60 • 24 Months Adverse events were reviewed by an independent Medical Monitor. MedDRA Lower-Level Terms (LLTs) were assigned by a certified MedDRA coder. The LLTs were mapped to their corresponding Preferred Terms (PTs) and System Organ Categories (SOCs).
Eye disorders Eye disorders	1.7% 1/60 • 24 Months Adverse events were reviewed by an independent Medical Monitor. MedDRA Lower-Level Terms (LLTs) were assigned by a certified MedDRA coder. The LLTs were mapped to their corresponding Preferred Terms (PTs) and System Organ Categories (SOCs).
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	1.7% 1/60 • 24 Months Adverse events were reviewed by an independent Medical Monitor. MedDRA Lower-Level Terms (LLTs) were assigned by a certified MedDRA coder. The LLTs were mapped to their corresponding Preferred Terms (PTs) and System Organ Categories (SOCs).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant, and unspecified (incl cysts and polyps)	1.7% 1/60 • 24 Months Adverse events were reviewed by an independent Medical Monitor. MedDRA Lower-Level Terms (LLTs) were assigned by a certified MedDRA coder. The LLTs were mapped to their corresponding Preferred Terms (PTs) and System Organ Categories (SOCs).
Nervous system disorders Nervous system disorders	3.3% 2/60 • 24 Months Adverse events were reviewed by an independent Medical Monitor. MedDRA Lower-Level Terms (LLTs) were assigned by a certified MedDRA coder. The LLTs were mapped to their corresponding Preferred Terms (PTs) and System Organ Categories (SOCs).
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic, and mediastinal disorders	3.3% 2/60 • 24 Months Adverse events were reviewed by an independent Medical Monitor. MedDRA Lower-Level Terms (LLTs) were assigned by a certified MedDRA coder. The LLTs were mapped to their corresponding Preferred Terms (PTs) and System Organ Categories (SOCs).
Surgical and medical procedures Surgical and medical procedures	5.0% 3/60 • 24 Months Adverse events were reviewed by an independent Medical Monitor. MedDRA Lower-Level Terms (LLTs) were assigned by a certified MedDRA coder. The LLTs were mapped to their corresponding Preferred Terms (PTs) and System Organ Categories (SOCs).
Vascular disorders Vascular disorders	16.7% 10/60 • 24 Months Adverse events were reviewed by an independent Medical Monitor. MedDRA Lower-Level Terms (LLTs) were assigned by a certified MedDRA coder. The LLTs were mapped to their corresponding Preferred Terms (PTs) and System Organ Categories (SOCs).

Other adverse events

Measure	PQ Bypass Stent Graft System n=60 participants at risk The PQ Bypass™ Stent Graft System is intended for patients with atherosclerotic lesions of the SFA PQ Bypass Stent Graft System: The PQ Bypass™ Stent Graft System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery, with reference vessel diameters of 5.0 to 6.7 mm and lesion lengths up to 180 mm.
Cardiac disorders Cardiac disorders	8.3% 5/60 • 24 Months Adverse events were reviewed by an independent Medical Monitor. MedDRA Lower-Level Terms (LLTs) were assigned by a certified MedDRA coder. The LLTs were mapped to their corresponding Preferred Terms (PTs) and System Organ Categories (SOCs).
General disorders General disorders and administration site conditions	35.0% 21/60 • 24 Months Adverse events were reviewed by an independent Medical Monitor. MedDRA Lower-Level Terms (LLTs) were assigned by a certified MedDRA coder. The LLTs were mapped to their corresponding Preferred Terms (PTs) and System Organ Categories (SOCs).
Infections and infestations Infections and infestations	5.0% 3/60 • 24 Months Adverse events were reviewed by an independent Medical Monitor. MedDRA Lower-Level Terms (LLTs) were assigned by a certified MedDRA coder. The LLTs were mapped to their corresponding Preferred Terms (PTs) and System Organ Categories (SOCs).
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	5.0% 3/60 • 24 Months Adverse events were reviewed by an independent Medical Monitor. MedDRA Lower-Level Terms (LLTs) were assigned by a certified MedDRA coder. The LLTs were mapped to their corresponding Preferred Terms (PTs) and System Organ Categories (SOCs).
Metabolism and nutrition disorders Metabolism and nutrition disorders	5.0% 3/60 • 24 Months Adverse events were reviewed by an independent Medical Monitor. MedDRA Lower-Level Terms (LLTs) were assigned by a certified MedDRA coder. The LLTs were mapped to their corresponding Preferred Terms (PTs) and System Organ Categories (SOCs).
Nervous system disorders Nervous system disorders	1.7% 1/60 • 24 Months Adverse events were reviewed by an independent Medical Monitor. MedDRA Lower-Level Terms (LLTs) were assigned by a certified MedDRA coder. The LLTs were mapped to their corresponding Preferred Terms (PTs) and System Organ Categories (SOCs).
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	1.7% 1/60 • 24 Months Adverse events were reviewed by an independent Medical Monitor. MedDRA Lower-Level Terms (LLTs) were assigned by a certified MedDRA coder. The LLTs were mapped to their corresponding Preferred Terms (PTs) and System Organ Categories (SOCs).
Surgical and medical procedures Surgical and medical procedures	1.7% 1/60 • 24 Months Adverse events were reviewed by an independent Medical Monitor. MedDRA Lower-Level Terms (LLTs) were assigned by a certified MedDRA coder. The LLTs were mapped to their corresponding Preferred Terms (PTs) and System Organ Categories (SOCs).
Vascular disorders Vascular disorders	18.3% 11/60 • 24 Months Adverse events were reviewed by an independent Medical Monitor. MedDRA Lower-Level Terms (LLTs) were assigned by a certified MedDRA coder. The LLTs were mapped to their corresponding Preferred Terms (PTs) and System Organ Categories (SOCs).

Additional Information

Mohamed Moawad

Endologix

Phone: 949-595-7244

Email: mmoawad@endologix.com

Results disclosure agreements

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