Peripheral Arterial Disease
Conditions
Brief summary
Prospective, single-arm, multi-center, international clinical investigation to evaluate the safety and effectiveness of the PQ Bypass System to access, deliver guidewires, and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.
Detailed description
The DETOUR2 study is a prospective, single-arm, multi-center, international, non-randomized, safety and effectiveness clinical investigation of the PQ Bypass system. The PQ Bypass System is intended to improve blood flow in patients with symptomatic peripheral arterial disease due to symptomatic femoropopliteal chronic total occlusions ≥ 20 cm (TASC D) that can include de novo, restenotic, or in-stent restenotic lesions; or Symptomatic femoropopliteal lesions ≥ 24 cm (total lesion length) that can include a chronic total occlusion or a ≥70% lesion that includes de novo, restenotic or in-stent restenosis (complex TASC C), with reference vessel diameters ranging from 5.0 - 6.7 mm, by investigator visual assessment.
Interventions
DEVICEDETOUR System
The DETOUR System is intended to improve blood flow in patients with peripheral arterial disease in symptomatic femoropopliteal lesions due to chronic total occlusions ≥ 20 cm (TASC D) that can include de novo, restenotic, or in-stent restenotic lesions; or total lesion lengths ≥24 cm that can include chronic total occlusions or a ≥70% lesion that includes de novo, restenotic or in-stent restenosis (complex TASC C).
Sponsors
Endologix
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
All subjects are required to meet the following inclusion criteria in order to be considered eligible for participation in the study: General Inclusion Criteria 1. Age \> 18 and ≤ 90 years of age. 2. Willing and able to provide informed consent. 3. Subject is willing to undergo all follow-up assessments according to the specified schedule over 36 months. Clinical Inclusion Criteria 4. Chronic, symptomatic lower limb ischemia defined as Rutherford clinical categories 3, 4, or 5. 5. Venous Clinical Severity Score \< 3. 6. Subject is a suitable candidate for angiography and endovascular intervention and, if required, is eligible for standard surgical repair. Angiographic Inclusion Criteria 7. Symptomatic femoropopliteal chronic total occlusions ≥ 20 cm (TASC D) that can include de novo, restenotic, or in-stent restenotic lesions; or Symptomatic femoropopliteal lesions ≥ 24 cm (total lesion length) that can include a chronic total occlusion or a ≥70% lesion that includes de novo, restenotic or in-stent restenosis (complex TASC C), by investigator visual assessment. 8. Reference vessel diameter ≥ 4.5 and ≤ 6.7 mm, by investigator visual assessment. 9. Subject has a patent popliteal artery (\<50% stenosis) distal to the landing zone 10. Able to successfully access the SFA origin for entry of the crossing device. 11. At least one patent infrapopliteal vessel (\<50% stenosis) with run-off to the ankle or foot. 12. A significant stenosis (≥ 50%) or occlusion of an ipsilateral, inflow artery (e.g. aortoiliac, common femoral) must be successfully treated (use of investigational treatment prohibited) prior to treatment of the target lesion. Successful treatment is defined as no complications and less than 30% residual stenosis following intervention. General
Exclusion criteria
1. Participating in another investigational clinical study. 2. Anticipated life expectancy less than 1 year or medical comorbid condition(s) that could limit the subject's ability to comply with the requirements of the trial. 3. Subject has other medical, social or psychological problems that, in the opinion of the investigator, preclude them from receiving this treatment, and the procedures and evaluations pre- and post-treatment. Clinical
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Patency | 12 months | Primary patency at 12 months as evidenced by a peak systolic velocity ratio (PSVR) ≤2.5 from DUS and no clinically-driven re-intervention within the stented segment. |
| Major Adverse Events at 30 Days | 30 days | Freedom from a Major Adverse Event (MAE) at 30 days post-procedure (defined as any occurrence of the following events: Death, Clinically-Driven Target Lesion Revascularization (CD-TLR), Major Amputation of(above the Treated Limb,ankle), Symptomatic Deep Vein Thrombosis (DVT), Pulmonary Embolism, or procedure-related bleeding requiring any transfusion of packed red blood cells or surgery). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stent Graft Separation and Migration | 30 Days | Stent graft separation and migration identified via ultrasound imaging |
| Stent Graft Separation and Migration Via 12-Month X-Ray | 12 Months | Stent graft separation and migration identified via X-ray |
| Stent Graft Fracture Via 12-Month X-Ray | 12-Months | Stent graft fracture identified via X-ray |
Countries
Germany, Latvia, United States
Participant flow
Recruitment details
Enrollment in the DETOUR 2 study was completed on 05-October-2020. All eligible subjects completed the 30-day, follow-up visit, per the protocol. Compliance at the 6, 12, and 24-month follow-up visits was 95.5%, 91.9%, and 87.05%, respectively.
Pre-assignment details
The DETOUR 2 study enrolled subjects at 32 US and 4 OUS sites 'All Subjects' (n=202 enrolled)
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Intention to Treat (ITT) All Subjects This is a prospective, single-arm, multi-center, international clinical investigation to evaluate the safety and effectiveness of the PQ Bypass System, delivery guidewires, and implant stent grafts for percutaneous femoropopliteal bypass. The primary analysis population will include 202 subjects. | 202 |
| Total | 202 |
Baseline characteristics
| Characteristic | Single Arm Intention to Treat (ITT) All Subjects |
|---|---|
| Age, Continuous | 68.9 Years |
| Congestive Heart Failure | 25 Participants |
| History of Diabetes Type 1 | 1 Participants |
| History of Diabetes Type 2 | 69 Participants |
| History of Smoking Current/Previous | 184 Participants |
| History of Smoking Never | 18 Participants |
| Lesion Length | 327.14 mm STANDARD_DEVIATION 61.376 |
| Number of Run-Off Vessels 1 | 35 Participants |
| Number of Run-Off Vessels 2 | 129 Participants |
| Number of Run-Off Vessels 3 | 23 Participants |
| Previous Peripheral Intervention | 121 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 175 Participants |
| Region of Enrollment Germany | 23 participants |
| Region of Enrollment Latvia | 26 participants |
| Region of Enrollment United States | 153 participants |
| Renal Insufficiency | 22 Participants |
| Rutherford clinical category Grade 3 | 157 Participants |
| Rutherford clinical category Grade 4 | 36 Participants |
| Rutherford clinical category Grade 5 | 9 Participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 149 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 14 / 202 |
| other Total, other adverse events | 142 / 202 |
| serious Total, serious adverse events | 130 / 202 |
Outcome results
Primary
Major Adverse Events at 30 Days
Freedom from a Major Adverse Event (MAE) at 30 days post-procedure (defined as any occurrence of the following events: Death, Clinically-Driven Target Lesion Revascularization (CD-TLR), Major Amputation of(above the Treated Limb,ankle), Symptomatic Deep Vein Thrombosis (DVT), Pulmonary Embolism, or procedure-related bleeding requiring any transfusion of packed red blood cells or surgery).
Time frame: 30 days
Population: MAEs at 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Subjects Intent to Treat (ITT) | Major Adverse Events at 30 Days | Procedure Related Bleeding | 7 Number of Events |
| All Subjects Intent to Treat (ITT) | Major Adverse Events at 30 Days | MAE | 14 Number of Events |
| All Subjects Intent to Treat (ITT) | Major Adverse Events at 30 Days | Death | 0 Number of Events |
| All Subjects Intent to Treat (ITT) | Major Adverse Events at 30 Days | CD-TLR | 0 Number of Events |
| All Subjects Intent to Treat (ITT) | Major Adverse Events at 30 Days | Amputation of Treated Limb | 0 Number of Events |
| All Subjects Intent to Treat (ITT) | Major Adverse Events at 30 Days | Deep Vein Thrombosis (DVT) | 5 Number of Events |
| All Subjects Intent to Treat (ITT) | Major Adverse Events at 30 Days | Pulmonary Embolism (PE) | 0 Number of Events |
Comparison: The primary safety endpoint hypotheses are:~* H0: 30-day Freedom from MAE rate of the PQ Bypass System~ ≤84%~* HA: 30-day Freedom from MAE rate of the PQ Bypass System \>84%
Primary
Primary Patency
Primary patency at 12 months as evidenced by a peak systolic velocity ratio (PSVR) ≤2.5 from DUS and no clinically-driven re-intervention within the stented segment.
Time frame: 12 months
Population: Number at Risk/Total Number of Events
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects Intent to Treat (ITT) | Primary Patency | 72.3 Percentage of Participants |
Comparison: The primary effectiveness endpoint is defined as primary patency at 12 months as evidenced by a peak systolic velocity ratio (PSVR)~≤2.5 from DUS and no clinically-driven re-intervention within the stented segment. The primary effectiveness endpoint hypotheses are:~* H0: 12-month success rate of the PQ Bypass System ≤60.4%~* HA: 12-month success rate of the PQ Bypass System \>60.4%
Secondary
Stent Graft Fracture Via 12-Month X-Ray
Stent graft fracture identified via X-ray
Time frame: 12-Months
Population: Based on number of subjects with available data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Subjects Intent to Treat (ITT) | Stent Graft Fracture Via 12-Month X-Ray | 0 Number of Subjects |
Secondary
Stent Graft Separation and Migration
Stent graft separation and migration identified via ultrasound imaging
Time frame: 30 Days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Subjects Intent to Treat (ITT) | Stent Graft Separation and Migration | Stent Graft Separation | 0 Number of Subjects |
| All Subjects Intent to Treat (ITT) | Stent Graft Separation and Migration | Stent Graft Migration | 0 Number of Subjects |
| All Subjects Intent to Treat (ITT) | Stent Graft Separation and Migration | Stent Graft Separation or Migration | 0 Number of Subjects |
Secondary
Stent Graft Separation and Migration Via 12-Month X-Ray
Stent graft separation and migration identified via X-ray
Time frame: 12 Months
Population: 12 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Subjects Intent to Treat (ITT) | Stent Graft Separation and Migration Via 12-Month X-Ray | Stent Graft Separation | 1 Number of Subjects with available data |
| All Subjects Intent to Treat (ITT) | Stent Graft Separation and Migration Via 12-Month X-Ray | Stent Graft Migration | 3 Number of Subjects with available data |
| All Subjects Intent to Treat (ITT) | Stent Graft Separation and Migration Via 12-Month X-Ray | Stent Graft Separation or Migration | 3 Number of Subjects with available data |