Trial Outcomes & Findings for DETOUR I Clinical Study for Percutaneous Femoropopliteal Bypass (NCT NCT02471638)

Last Updated: 2025-05-23

Results Overview

Rate of primary patency. Primary patency defined as: no evidence of clinically significant stenosis (≥50%) within the stent graft or immediately above or below the treated arterial segment based on duplex ultrasound (systolic velocity ratio of \>2.5).

Recruitment status

COMPLETED

Study phase

Target enrollment

78 participants

Primary outcome timeframe

6 Months

Results posted on

2025-05-23

Participant Flow

78 patients enrolled over the course of 24 months at 8 investigational sites

Unit of analysis: Lesions

Participant milestones

Participant milestones
Measure	Enrolled and Treated Patients All patients enrolled in the DETOUR1 Clinical study to evaluate the PQ Bypass Detour System for Femoropopliteal Bypass to complete percutaneous fem-pop bypass. All patients were enrolled in the cath lab with a single procedure using the PQ Bypass Detour System, comprised of the PQ Crossing Device and the Torus Stent Graft System. Patients were followed to 24 months.
Overall Study STARTED	78 82
Overall Study 12 Month Results	77 79
Overall Study COMPLETED	68 68
Overall Study NOT COMPLETED	10 14

Reasons for withdrawal

Reasons for withdrawal
Measure	Enrolled and Treated Patients All patients enrolled in the DETOUR1 Clinical study to evaluate the PQ Bypass Detour System for Femoropopliteal Bypass to complete percutaneous fem-pop bypass. All patients were enrolled in the cath lab with a single procedure using the PQ Bypass Detour System, comprised of the PQ Crossing Device and the Torus Stent Graft System. Patients were followed to 24 months.
Overall Study Early Term Withdrawal	10

Baseline Characteristics

DETOUR I Clinical Study for Percutaneous Femoropopliteal Bypass

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enrolled and Treated Patients n=82 Lesions All patients and limbs enrolled in the DETOUR1 Study
Age, Continuous	65 years STANDARD_DEVIATION 7 • n=78 Participants
Sex: Female, Male Female	13 Participants n=78 Participants
Sex: Female, Male Male	65 Participants n=78 Participants
Region of Enrollment New Zealand	1 Lesions n=82 Lesions
Region of Enrollment Latvia	34 Lesions n=82 Lesions
Region of Enrollment Poland	36 Lesions n=82 Lesions
Region of Enrollment Italy	1 Lesions n=82 Lesions
Region of Enrollment Chile	7 Lesions n=82 Lesions
Region of Enrollment Germany	3 Lesions n=82 Lesions
Hypertension	65 Participants n=78 Participants
Diabetes mellitus	20 Participants n=78 Participants
Hypercholesterolemia	31 Participants n=78 Participants
History of Coronary Artery Disease (CAD)	34 Participants n=78 Participants
History of smoking	68 Participants n=78 Participants
Previous peripheral vascular intervention	19 Participants n=78 Participants
SFA lesion length	371 mm STANDARD_DEVIATION 55 • n=82 Lesions
Ankle Brachial Index (ABI)	0.64 Ratio STANDARD_DEVIATION 0.17 • n=82 Lesions
TASC Lesion Type TASC Lesion Type C	46 Lesions n=82 Lesions
TASC Lesion Type TASC Lesion Type D	36 Lesions n=82 Lesions
Chronic Total Occlusion	79 Lesions n=82 Lesions
Rutherford Class Rutherford Class 3	76 Lesions n=82 Lesions
Rutherford Class Rutherford Class 4	5 Lesions n=82 Lesions
Rutherford Class Rutherford Class 5	1 Lesions n=82 Lesions
Calcification Mild	15 Lesions n=82 Lesions
Calcification Moderate	11 Lesions n=82 Lesions
Calcification Severe	55 Lesions n=82 Lesions
Calcification N/A	1 Lesions n=82 Lesions
Patent Tibial Runoff Vessels 1	6 Lesions n=82 Lesions
Patent Tibial Runoff Vessels 2	23 Lesions n=82 Lesions
Patent Tibial Runoff Vessels 3	49 Lesions n=82 Lesions
Patent Tibial Runoff Vessels N/A	4 Lesions n=82 Lesions

PRIMARY outcome

Timeframe: 6 Months

Outcome measures

Outcome measures
Measure	Enrolled and Treated Patients n=81 Lesions All limbs enrolled in the DETOUR1 Study
Number of Lesions With Primary Patency	72 Lesions

PRIMARY outcome

Timeframe: One Month

composite endpoint of death, CD-TVR, or major target limb amputation in all patients at One-month post procedure

Outcome measures

Outcome measures
Measure	Enrolled and Treated Patients n=81 Lesions All limbs enrolled in the DETOUR1 Study
Number of Lesions With Any Major Adverse Event (MAE) at One Month Post-procedure MAE	2 Lesions
Number of Lesions With Any Major Adverse Event (MAE) at One Month Post-procedure Free from MAE	79 Lesions

SECONDARY outcome

Timeframe: One Month

Outcome Measures of death, CD-TVR, or major target limb amputation as independent events one month post-procedure

Outcome measures

Outcome measures
Measure	Enrolled and Treated Patients n=81 Lesions All limbs enrolled in the DETOUR1 Study
Number of Lesions With Each Major Adverse Event (MAE) at One Month Post-procedure Death	0 Lesions
Number of Lesions With Each Major Adverse Event (MAE) at One Month Post-procedure CD-TVR	2 Lesions
Number of Lesions With Each Major Adverse Event (MAE) at One Month Post-procedure Target Limb Amputation	0 Lesions
Number of Lesions With Each Major Adverse Event (MAE) at One Month Post-procedure Free from MAE	79 Lesions

SECONDARY outcome

Timeframe: 12 Months

Primary patency defined as: no evidence of clinically significant stenosis (≥50%) within the stent graft or immediately above or below the treated arterial segment based on duplex ultrasound (systolic velocity ratio of \>2.5).

Outcome measures

Outcome measures
Measure	Enrolled and Treated Patients n=80 Lesions All limbs enrolled in the DETOUR1 Study
Percentage of Lesions With Primary Patency at 12 Months Post-Procedure	81 percentage of lesions Standard Deviation 4

SECONDARY outcome

Timeframe: One Month

Major Adverse Vascular Events-stent graft thrombosis, target limb amputation, clinically apparent distal embolization with tissue loss, procedure-related arterial rupture, acute limb ischemia, and bleeding events requiring any transfusion. Major bleeding required blood transfusion \>2 units, and symptomatic deep vein thrombosis on ipsilateral limb

Outcome measures

Outcome measures
Measure	Enrolled and Treated Patients n=81 Lesions All limbs enrolled in the DETOUR1 Study
Major Adverse Vascular Event (MAVE) Rate Stent thrombosis	3 Lesions
Major Adverse Vascular Event (MAVE) Rate Clinically apparent distal embolization	0 Lesions
Major Adverse Vascular Event (MAVE) Rate Procedure-related arterial rupture	0 Lesions
Major Adverse Vascular Event (MAVE) Rate Acute limb ischemia	0 Lesions
Major Adverse Vascular Event (MAVE) Rate Bleeding event requiring transfusion	1 Lesions
Major Adverse Vascular Event (MAVE) Rate Free from MAVE	77 Lesions
Major Adverse Vascular Event (MAVE) Rate Symptomatic Deep Vein Thrombosis on Ipsilateral Limb	1 Lesions

SECONDARY outcome

Timeframe: One Month

Rate of Symptomatic Deep Vein Thrombosis in target limb at one month time point.

Outcome measures

Outcome measures
Measure	Enrolled and Treated Patients n=81 Lesions All limbs enrolled in the DETOUR1 Study
Number of Lesions With Symptomatic Deep Vein Thromboses in Target Limb DVT in Target Limb	1 Lesions
Number of Lesions With Symptomatic Deep Vein Thromboses in Target Limb Freedom from DVT in Target Limb	80 Lesions

SECONDARY outcome

Timeframe: 12 Months

Number of occurrences of all cause death, CD-TVR, or major target limb amputation

Outcome measures

Outcome measures
Measure	Enrolled and Treated Patients n=79 Events All limbs enrolled in the DETOUR1 Study
Number of Major Adverse Events at the 12-Month Time Point Death	1 Events
Number of Major Adverse Events at the 12-Month Time Point CD-TVR	12 Events
Number of Major Adverse Events at the 12-Month Time Point Target limb amputation	0 Events
Number of Major Adverse Events at the 12-Month Time Point Freedom from MAE	66 Events

SECONDARY outcome

Timeframe: 3 Years

Number of occurrences of all cause death, CD-TVR, or major target limb amputation

Outcome measures

Outcome measures
Measure	Enrolled and Treated Patients n=29 Events All limbs enrolled in the DETOUR1 Study
Number of Major Adverse Events at the 3 Year Time Point Death	3 Events
Number of Major Adverse Events at the 3 Year Time Point Target limb amputation	1 Events
Number of Major Adverse Events at the 3 Year Time Point CD-TVR	27 Events

SECONDARY outcome

Timeframe: 3 Years

Outcome measures

Outcome measures
Measure	Enrolled and Treated Patients n=67 Participants All limbs enrolled in the DETOUR1 Study
Major Adverse Vascular Event (MAVE) Rate at 3 Years Stent Graft Thrombosis (absence of TVR)	15 Participants
Major Adverse Vascular Event (MAVE) Rate at 3 Years Clinically Apparent Distal Embolization	0 Participants
Major Adverse Vascular Event (MAVE) Rate at 3 Years Procedure Related Arterial Rupture	0 Participants
Major Adverse Vascular Event (MAVE) Rate at 3 Years Acute Limb Ischemia	0 Participants
Major Adverse Vascular Event (MAVE) Rate at 3 Years Major Blood Loss Related to the PQ Bypass procedure requiring >2 units or packed RBC	1 Participants
Major Adverse Vascular Event (MAVE) Rate at 3 Years Symptomatic Deep Vein Thrombosis on Ipsilateral Limb	2 Participants

Adverse Events

Enrolled and Treated Patients

Serious events: 14 serious events

Other events: 65 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Enrolled and Treated Patients n=78 participants at risk All limbs enrolled in the DETOUR1 Study of the enrolled and treated patients. Some subjects had bilateral enrollment (the Detour Procedure was performed on both legs), because of this, the all-cause mortality rate has a different denominator than the other limb related adverse events. A total of 78 participants were enrolled (82 lesions), and one patient was enrolled but not treated due to technical failure of the device. The all-cause mortality denominators (at Risk values) are different from the other limb related adverse events. The all-cause mortality rate is reported at 1/77.
Surgical and medical procedures Clinically Driven Target Vessel Revascularization (CD-TVR)	15.4% 12/78 • Number of events 12 • Adverse Events were collected at each follow-up visit through 3 years.
Surgical and medical procedures Target Limb Amputation	0.00% 0/78 • Adverse Events were collected at each follow-up visit through 3 years.
Vascular disorders Stent Thrombosis	16.7% 13/78 • Number of events 13 • Adverse Events were collected at each follow-up visit through 3 years.
Vascular disorders Clinically apparent distal embolization	0.00% 0/78 • Adverse Events were collected at each follow-up visit through 3 years.
Vascular disorders Procedure-related arterial rupture	0.00% 0/78 • Adverse Events were collected at each follow-up visit through 3 years.
Vascular disorders Acute limb ischemia	0.00% 0/78 • Adverse Events were collected at each follow-up visit through 3 years.
Surgical and medical procedures Bleeding event requiring transfusion	1.3% 1/78 • Number of events 1 • Adverse Events were collected at each follow-up visit through 3 years.
Vascular disorders Deep Vein Thrombosis (DVT)	2.6% 2/78 • Number of events 2 • Adverse Events were collected at each follow-up visit through 3 years.

Other adverse events

Other adverse events
Measure	Enrolled and Treated Patients n=78 participants at risk All limbs enrolled in the DETOUR1 Study of the enrolled and treated patients. Some subjects had bilateral enrollment (the Detour Procedure was performed on both legs), because of this, the all-cause mortality rate has a different denominator than the other limb related adverse events. A total of 78 participants were enrolled (82 lesions), and one patient was enrolled but not treated due to technical failure of the device. The all-cause mortality denominators (at Risk values) are different from the other limb related adverse events. The all-cause mortality rate is reported at 1/77.
Vascular disorders Access site hemorrhage or hematoma	3.8% 3/78 • Adverse Events were collected at each follow-up visit through 3 years.
Blood and lymphatic system disorders Anemia	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.
Cardiac disorders angina pectoris	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.
Vascular disorders contralateral arteria femoral profunda occlusion	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.
Cardiac disorders ATRIAL FIBRILLATION	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.
Injury, poisoning and procedural complications Bleeding Complications	2.6% 2/78 • Adverse Events were collected at each follow-up visit through 3 years.
Cardiac disorders Chronic Heart Failure	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.
Cardiac disorders Coronary artery stenosis	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.
Musculoskeletal and connective tissue disorders Degenerative lumbar spondylosis	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.
Metabolism and nutrition disorders Diabetes mellitus	2.6% 2/78 • Adverse Events were collected at each follow-up visit through 3 years.
Vascular disorders Deep Vein Thrombosis	5.1% 4/78 • Adverse Events were collected at each follow-up visit through 3 years.
Injury, poisoning and procedural complications Drug Reaction	3.8% 3/78 • Adverse Events were collected at each follow-up visit through 3 years.
Blood and lymphatic system disorders Edema	9.0% 7/78 • Adverse Events were collected at each follow-up visit through 3 years.
Vascular disorders Stent Graft thrombosis	16.7% 13/78 • Adverse Events were collected at each follow-up visit through 3 years.
General disorders Fever	3.8% 3/78 • Adverse Events were collected at each follow-up visit through 3 years.
Respiratory, thoracic and mediastinal disorders Hemoptysis	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.
Cardiac disorders Diagnostic Hospitalization	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.
Vascular disorders Stent Graft Occlusion	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.
Injury, poisoning and procedural complications Arterio-Venous (A-V) Fistula between Posterior Tibial Artery	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.
Skin and subcutaneous tissue disorders Basal Cell Carcinoma	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.
General disorders dislodgment of graft neo intima	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.
Vascular disorders Endarteritis obliterans	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.
Respiratory, thoracic and mediastinal disorders Exacerbation of Shortness of breath	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.
Vascular disorders Reflux	5.1% 4/78 • Adverse Events were collected at each follow-up visit through 3 years.
Vascular disorders Hypertension	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.
Injury, poisoning and procedural complications Hematoma	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.
Vascular disorders Occlusion of Contralateral Femoropopliteal Bypass	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.
Injury, poisoning and procedural complications Stent Graft Migration	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.
General disorders Pain	5.1% 4/78 • Adverse Events were collected at each follow-up visit through 3 years.
Vascular disorders Stent Graft Stenosis	12.8% 10/78 • Adverse Events were collected at each follow-up visit through 3 years.
General disorders Rectal Bleeding	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.
Vascular disorders Reocclusion of bypass graft	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.
Vascular disorders Profundua Femoralis Stenosis	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.
Vascular disorders Target Vessel Revascularization (TVR)	3.8% 3/78 • Adverse Events were collected at each follow-up visit through 3 years.
Vascular disorders Arterial Ulcer	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.
Vascular disorders transient ischemic attack (TIA)	1.3% 1/78 • Adverse Events were collected at each follow-up visit through 3 years.

Additional Information

Tammy Stiver

Endologix

Phone: 5136731452

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60