Peripheral Arterial Disease
Conditions
Brief summary
To assess the safety and performance of the PQ Bypass System to access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.
Detailed description
Prospective, single-arm, multi-center, international, non-randomized, pre-market, safety and effectiveness clinical investigation evaluating the PQ Bypass Systems to access, deliver guidewires and implant stent grafts for a percutaneous femoropopliteal (fem-pop) bypass.
Interventions
DEVICEPQ Bypass System for Femoropopliteal Bypass
To access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.
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
* Willing and able to provide informed consent * Age 18 or older * Rutherford Classification of 3-5 * Patent iliac and femoral arteries/veins and access vessels, of sufficient size and morphology (including tortuosity), to allow endovascular access with 8 Fr. introducer sheath * Femoro-popliteal lesions ≥10 cm in length considered to be: * Chronic total occlusion (100% stenosis) * Diffuse stenosis (\>50% stenosis) with moderate to heavy calcification * In-stent restenosis (\>50% stenosis) * Proximal and distal target vessels are 5.4-7.0 mm in diameter * Orifice and proximal 1 cm of SFA is patent * Patent popliteal artery 3 cm proximal to tibial plateau * At least 1 patent tibial artery to the foot * Patent femoral vein ≥ 10 mm in diameter or duplicate femoral vein * Subject has \> one year life expectancy
Exclusion criteria
* Bypass length required \> 30 cm * History of deep vein thrombosis * Has a known hypersensitivities, allergies or contraindications to: nitinol, PTFE; aspirin, heparin, antiplatelet, anticoagulant or thrombolytic therapy; or anticoagulation or contrast media that is not amenable to pre-treatment; * Has a known history of intracranial bleeding or aneurysm, myocardial infarction or stroke within the last 12 months * Pregnant or nursing * Untreated flow-limiting aortoiliac occlusive disease * Has renal failure (eGFR \< 30mL/min) * Major distal amputation (above the transmetatarsal) in the study or non-study limb * Patient has had a revascularization procedure on the target limb within 30 days * Patient has a planned amputation of the target limb * Previous bypass surgery on the target limb * Patient is participating in another clinical study for which follow-up is currently on going. * Patient has a condition that in the view of the investigator precludes participation in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Lesions With Primary Patency | 6 Months | 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). |
| Number of Lesions With Any Major Adverse Event (MAE) at One Month Post-procedure | One Month | composite endpoint of death, CD-TVR, or major target limb amputation in all patients at One-month post procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Lesions With Each Major Adverse Event (MAE) at One Month Post-procedure | One Month | Outcome Measures of death, CD-TVR, or major target limb amputation as independent events one month post-procedure |
| Percentage of Lesions With Primary Patency at 12 Months Post-Procedure | 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). |
| Major Adverse Vascular Event (MAVE) Rate | 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 |
| Number of Lesions With Symptomatic Deep Vein Thromboses in Target Limb | One Month | Rate of Symptomatic Deep Vein Thrombosis in target limb at one month time point. |
| Number of Major Adverse Events at the 12-Month Time Point | 12 Months | Number of occurrences of all cause death, CD-TVR, or major target limb amputation |
| Number of Major Adverse Events at the 3 Year Time Point | 3 Years | Number of occurrences of all cause death, CD-TVR, or major target limb amputation |
| Major Adverse Vascular Event (MAVE) Rate at 3 Years | 3 Years | 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. |
| Technical Success | Index Procedure | Technical Success defined as successful delivery of the investigational devices to the identified area and removal of delivery system. |
Countries
Chile, Germany, Italy, Latvia, New Zealand, Poland
Contacts
PRINCIPAL_INVESTIGATORDierk Scheinert, PhD
University of Leipzig
Participant flow
Recruitment details
78 patients enrolled over the course of 24 months at 8 investigational sites
Participants by arm
| Arm | Count |
|---|---|
| Enrolled and Treated Patients All patients and limbs enrolled in the DETOUR1 Study | 78 |
| Enrolled and Treated Patients All patients and limbs enrolled in the DETOUR1 Study | 82 |
| Total | 160 |
Baseline characteristics
| Characteristic | Enrolled and Treated Patients |
|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 7 |
| Ankle Brachial Index (ABI) | 0.64 Ratio STANDARD_DEVIATION 0.17 |
| Calcification Mild | 15 Lesions |
| Calcification Moderate | 11 Lesions |
| Calcification N/A | 1 Lesions |
| Calcification Severe | 55 Lesions |
| Chronic Total Occlusion | 79 Lesions |
| Diabetes mellitus | 20 Participants |
| History of Coronary Artery Disease (CAD) | 34 Participants |
| History of smoking | 68 Participants |
| Hypercholesterolemia | 31 Participants |
| Hypertension | 65 Participants |
| Patent Tibial Runoff Vessels 1 | 6 Lesions |
| Patent Tibial Runoff Vessels 2 | 23 Lesions |
| Patent Tibial Runoff Vessels 3 | 49 Lesions |
| Patent Tibial Runoff Vessels N/A | 4 Lesions |
| Previous peripheral vascular intervention | 19 Participants |
| Region of Enrollment Chile | 7 Lesions |
| Region of Enrollment Germany | 3 Lesions |
| Region of Enrollment Italy | 1 Lesions |
| Region of Enrollment Latvia | 34 Lesions |
| Region of Enrollment New Zealand | 1 Lesions |
| Region of Enrollment Poland | 36 Lesions |
| Rutherford Class Rutherford Class 3 | 76 Lesions |
| Rutherford Class Rutherford Class 4 | 5 Lesions |
| Rutherford Class Rutherford Class 5 | 1 Lesions |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 65 Participants |
| SFA lesion length | 371 mm STANDARD_DEVIATION 55 |
| TASC Lesion Type TASC Lesion Type C | 46 Lesions |
| TASC Lesion Type TASC Lesion Type D | 36 Lesions |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 78 |
| other Total, other adverse events | 65 / 78 |
| serious Total, serious adverse events | 14 / 78 |
Outcome results
Primary
Number of Lesions With Any Major Adverse Event (MAE) at One Month Post-procedure
composite endpoint of death, CD-TVR, or major target limb amputation in all patients at One-month post procedure
Time frame: One Month
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Enrolled and Treated Patients | Number of Lesions With Any Major Adverse Event (MAE) at One Month Post-procedure | MAE | 2 Lesions |
| Enrolled and Treated Patients | Number of Lesions With Any Major Adverse Event (MAE) at One Month Post-procedure | Free from MAE | 79 Lesions |
Primary
Number of Lesions With Primary Patency
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).
Time frame: 6 Months
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Enrolled and Treated Patients | Number of Lesions With Primary Patency | 72 Lesions |
Secondary
Major Adverse Vascular Event (MAVE) Rate
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
Time frame: One Month
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Enrolled and Treated Patients | Major Adverse Vascular Event (MAVE) Rate | Stent thrombosis | 3 Lesions |
| Enrolled and Treated Patients | Major Adverse Vascular Event (MAVE) Rate | Clinically apparent distal embolization | 0 Lesions |
| Enrolled and Treated Patients | Major Adverse Vascular Event (MAVE) Rate | Procedure-related arterial rupture | 0 Lesions |
| Enrolled and Treated Patients | Major Adverse Vascular Event (MAVE) Rate | Bleeding event requiring transfusion | 1 Lesions |
| Enrolled and Treated Patients | Major Adverse Vascular Event (MAVE) Rate | Free from MAVE | 77 Lesions |
| Enrolled and Treated Patients | Major Adverse Vascular Event (MAVE) Rate | Symptomatic Deep Vein Thrombosis on Ipsilateral Limb | 1 Lesions |
| Enrolled and Treated Patients | Major Adverse Vascular Event (MAVE) Rate | Acute limb ischemia | 0 Lesions |
Secondary
Major Adverse Vascular Event (MAVE) Rate at 3 Years
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.
Time frame: 3 Years
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Enrolled and Treated Patients | Major Adverse Vascular Event (MAVE) Rate at 3 Years | Stent Graft Thrombosis (absence of TVR) | 15 Participants |
| Enrolled and Treated Patients | Major Adverse Vascular Event (MAVE) Rate at 3 Years | Clinically Apparent Distal Embolization | 0 Participants |
| Enrolled and Treated Patients | Major Adverse Vascular Event (MAVE) Rate at 3 Years | Procedure Related Arterial Rupture | 0 Participants |
| Enrolled and Treated Patients | Major Adverse Vascular Event (MAVE) Rate at 3 Years | Acute Limb Ischemia | 0 Participants |
| Enrolled and Treated Patients | 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 |
| Enrolled and Treated Patients | Major Adverse Vascular Event (MAVE) Rate at 3 Years | Symptomatic Deep Vein Thrombosis on Ipsilateral Limb | 2 Participants |
Secondary
Number of Lesions With Each Major Adverse Event (MAE) at One Month Post-procedure
Outcome Measures of death, CD-TVR, or major target limb amputation as independent events one month post-procedure
Time frame: One Month
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Enrolled and Treated Patients | Number of Lesions With Each Major Adverse Event (MAE) at One Month Post-procedure | Death | 0 Lesions |
| Enrolled and Treated Patients | Number of Lesions With Each Major Adverse Event (MAE) at One Month Post-procedure | CD-TVR | 2 Lesions |
| Enrolled and Treated Patients | Number of Lesions With Each Major Adverse Event (MAE) at One Month Post-procedure | Target Limb Amputation | 0 Lesions |
| Enrolled and Treated Patients | Number of Lesions With Each Major Adverse Event (MAE) at One Month Post-procedure | Free from MAE | 79 Lesions |
Secondary
Number of Lesions With Symptomatic Deep Vein Thromboses in Target Limb
Rate of Symptomatic Deep Vein Thrombosis in target limb at one month time point.
Time frame: One Month
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Enrolled and Treated Patients | Number of Lesions With Symptomatic Deep Vein Thromboses in Target Limb | DVT in Target Limb | 1 Lesions |
| Enrolled and Treated Patients | Number of Lesions With Symptomatic Deep Vein Thromboses in Target Limb | Freedom from DVT in Target Limb | 80 Lesions |
Secondary
Number of Major Adverse Events at the 12-Month Time Point
Number of occurrences of all cause death, CD-TVR, or major target limb amputation
Time frame: 12 Months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrolled and Treated Patients | Number of Major Adverse Events at the 12-Month Time Point | CD-TVR | 12 Events |
| Enrolled and Treated Patients | Number of Major Adverse Events at the 12-Month Time Point | Death | 1 Events |
| Enrolled and Treated Patients | Number of Major Adverse Events at the 12-Month Time Point | Target limb amputation | 0 Events |
| Enrolled and Treated Patients | Number of Major Adverse Events at the 12-Month Time Point | Freedom from MAE | 66 Events |
Secondary
Number of Major Adverse Events at the 3 Year Time Point
Number of occurrences of all cause death, CD-TVR, or major target limb amputation
Time frame: 3 Years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enrolled and Treated Patients | Number of Major Adverse Events at the 3 Year Time Point | Death | 3 Events |
| Enrolled and Treated Patients | Number of Major Adverse Events at the 3 Year Time Point | Target limb amputation | 1 Events |
| Enrolled and Treated Patients | Number of Major Adverse Events at the 3 Year Time Point | CD-TVR | 27 Events |
Secondary
Percentage of Lesions With Primary Patency at 12 Months Post-Procedure
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).
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enrolled and Treated Patients | Percentage of Lesions With Primary Patency at 12 Months Post-Procedure | 81 percentage of lesions | Standard Deviation 4 |