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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm study | Experimental | PQ Bypass System for Femoropopliteal Bypass to complete percutaneous fem-pop bypass |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PQ Bypass System for Femoropopliteal Bypass | Device | To access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 6 Months |
| 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 | One Month |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | One Month |
| Percentage of Lesions With Primary Patency at 12 Months Post-Procedure |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Dierk Scheinert, PhD | University of Leipzig | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Católica de Chile | Santiago | Chile | ||||
| University of Leipzig Medical Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33429092 | Derived | Schneider PA, Krievins DK, Halena G, Schmidt A, Lyden S, Lee V, Hu M, Adelman M. Venous outcomes at 1 year after using the femoral vein as a conduit for passage of percutaneous femoropopliteal bypass. J Vasc Surg Venous Lymphat Disord. 2021 Sep;9(5):1266-1272.e3. doi: 10.1016/j.jvsv.2020.12.080. Epub 2021 Jan 8. | |
| 32276015 | Derived |
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78 patients enrolled over the course of 24 months at 8 investigational sites
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Overall Number of Baseline Participants enrolled 78, and Overall Number of Lesions (units) analyzed 82.
| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled and Treated Patients | All patients and limbs enrolled in the DETOUR1 Study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Count of Units | Lesions | 6 Months | Lesions | Lesions |
|
|
Adverse Events were collected at each follow-up visit through 3 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enrolled and Treated Patients | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Clinically Driven Target Vessel Revascularization (CD-TVR) | Surgical and medical procedures | MedDRA | Systematic Assessment | Target Vessel Revascularization due to linically 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Access site hemorrhage or hematoma | Vascular disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tammy Stiver | Endologix | 5136731452 | tstiver@endologix.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 23, 2017 | Oct 15, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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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). |
| 12 Months |
| 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 | One Month |
| 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. | One Month |
| 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 | 12 Months |
| 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 | 3 Years |
| 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. | 3 Years |
| Technical Success | Technical Success defined as successful delivery of the investigational devices to the identified area and removal of delivery system. | Index Procedure |
| Leipzig |
| 04103 |
| Germany |
| Ospedale San Raffaele | Milan | 20132 | Italy |
| Stradins University Hospital | Riga | LV-1002 | Latvia |
| Vascular Service | Auckland | 1023 | New Zealand |
| Gdansk Medical University | Gdansk | Poland |
| Poznan University of Medical Sciences | Poznan | 61-848 | Poland |
| Institute of Haematology Medicine Indira Gandhi | Warsaw | Poland |
| Krievins DK, Halena G, Scheinert D, Savlovskis J, Szopinski P, Kramer A, Ouriel K, Nair K, Holden A, Schmidt A. One-year results from the DETOUR I trial of the PQ Bypass DETOUR System for percutaneous femoropopliteal bypass. J Vasc Surg. 2020 Nov;72(5):1648-1658.e2. doi: 10.1016/j.jvs.2020.02.043. Epub 2020 Apr 8. |
| Lesions |
|
| years |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
| Region of Enrollment | Number | Lesions | Lesions |
|
|
| Hypertension | Count of Participants | Participants | Participants |
|
|
| Diabetes mellitus | Count of Participants | Participants | Participants |
|
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| Hypercholesterolemia | Count of Participants | Participants | Participants |
|
|
| History of Coronary Artery Disease (CAD) | Count of Participants | Participants | Participants |
|
|
| History of smoking | Count of Participants | Participants | Participants |
|
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| Previous peripheral vascular intervention | Count of Participants | Participants | Participants |
|
|
| SFA lesion length | Mean | Standard Deviation | mm | Lesions |
|
|
| Ankle Brachial Index (ABI) | Ankle Brachial Index is a measure of systolic blood pressure in the ankle divided by the systolic blood pressure in the brachial artery. lower ratios indicate a worse outcome. Ratios above 1.0 indicate non-compressible arteries Range measured at baseline in study- 0.34- 1.50 | Mean | Standard Deviation | Ratio | Lesions |
|
|
| TASC Lesion Type | TASC II divides anatomic distribution of lesions into femoral popliteal. Lesion patterns are grouped into A-D lesions. TASC A lesions are those that should have excellent results from endovascular management. TASC B lesions are those that should have good results from endovascular management, and endoluminal interventions should be the first treatment approach. TASC C lesions are those for which surgical management provides superior long-term results and endovascular techniques should be reserved for patients who are surgically high risk. TASC D lesions should be treated by open surgery. | Count of Units | Lesions | Lesions |
|
|
| Chronic Total Occlusion | Count of Units | Lesions | Lesions |
|
|
| Rutherford Class | Rutherford Classification is a system for grading clinical presentation of Peripheral Artery Disease (PAD) Classification 0- Asymptomatic-no hemodynamically significant occlusive disease Classification 1- Mild claudication Classification 2- Moderate claudication Classification 3- Severe claudication Classification 4- Ischemic rest pain Classification 5- Minor tissue loss-nonhealing ulcer, focal gangrene with diffuse pedal ischemia Classification 6- Major tissue loss-extending above Trans metatarsal level, functional foot no longer salvageable | Count of Units | Lesions | Lesions |
|
|
| Calcification | Count of Units | Lesions | Lesions |
|
|
| Patent Tibial Runoff Vessels | The number of patent tibial arteries in the treated leg to carry blood flow to the lower leg and foot. | Number | Lesions | Lesions |
|
|
| Lesions |
|
|
| 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 | Posted | Count of Units | Lesions | One Month | Lesions | Lesions |
|
|
|
| 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 | Posted | Count of Units | Lesions | One Month | Lesions | Lesions |
|
|
|
| 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). | Posted | Mean | Standard Deviation | percentage of lesions | 12 Months | Lesions | 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 | Posted | Count of Units | Lesions | One Month | Lesions | 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. | Posted | Count of Units | Lesions | One Month | Lesions | 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 | Posted | Number | Events | 12 Months | Events | 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 | Posted | Number | Events | 3 Years | Events | Events |
|
|
|
| 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. | Posted | Count of Participants | Participants | 3 Years |
|
|
|
| Secondary | Technical Success | Technical Success defined as successful delivery of the investigational devices to the identified area and removal of delivery system. | All patients enrolled in the DETOUR1 Clinical study | Posted | Number | Lesions | Index Procedure | Lesions | Lesions |
|
|
|
| 3 |
| 78 |
| 14 |
| 78 |
| 65 |
| 78 |
|
| Target Limb Amputation | Surgical and medical procedures | MedDRA | Systematic Assessment |
|
| Stent Thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Clinically apparent distal embolization | Vascular disorders | MedDRA | Systematic Assessment |
|
| Procedure-related arterial rupture | Vascular disorders | MedDRA | Systematic Assessment |
|
| Acute limb ischemia | Vascular disorders | MedDRA | Systematic Assessment |
|
| Bleeding event requiring transfusion | Surgical and medical procedures | MedDRA | Systematic Assessment | This event is subject specific, not lesion specific, therefore the number of participants at risk is adjusted |
|
| Deep Vein Thrombosis (DVT) | Vascular disorders | MedDRA | Systematic Assessment | Deep Vein Thrombosis |
|
| Anemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
|
| angina pectoris | Cardiac disorders | MedDRA | Systematic Assessment |
|
| contralateral arteria femoral profunda occlusion | Vascular disorders | MedDRA | Systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Bleeding Complications | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Minor bleeding |
|
| Chronic Heart Failure | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Degenerative lumbar spondylosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | MedDRA | Systematic Assessment | Not clinically significant |
|
| Drug Reaction | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Mild Allergic reaction to contrast media or periprocedural medication |
|
| Edema | Blood and lymphatic system disorders | MedDRA | Systematic Assessment | Swelling |
|
| Stent Graft thrombosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Fever | General disorders | MedDRA | Systematic Assessment |
|
| Hemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Diagnostic Hospitalization | Cardiac disorders | MedDRA | Systematic Assessment |
|
| Stent Graft Occlusion | Vascular disorders | MedDRA | Systematic Assessment |
|
| Arterio-Venous (A-V) Fistula between Posterior Tibial Artery | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Other: A-V Fistula between Posterior Tibial Artery |
|
| Basal Cell Carcinoma | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
| dislodgment of graft neo intima | General disorders | MedDRA | Systematic Assessment |
|
| Endarteritis obliterans | Vascular disorders | MedDRA | Systematic Assessment |
|
| Exacerbation of Shortness of breath | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Reflux | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
|
| Hematoma | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment | Patient received bruise on leg after fall in the garden |
|
| Occlusion of Contralateral Femoropopliteal Bypass | Vascular disorders | MedDRA | Systematic Assessment | Occlusion of Fem-pop bypass on contralateral limb |
|
| Stent Graft Migration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Pain | General disorders | MedDRA | Systematic Assessment | Pain in Lower limbs |
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| Stent Graft Stenosis | Vascular disorders | MedDRA | Systematic Assessment |
|
| Rectal Bleeding | General disorders | MedDRA | Systematic Assessment | This Adverse event is calculated per patient, not per lesion, so the denominator reflects this difference |
|
| Reocclusion of bypass graft | Vascular disorders | MedDRA | Systematic Assessment |
|
| Profundua Femoralis Stenosis | Vascular disorders | MedDRA | Systematic Assessment | Non target limb |
|
| Target Vessel Revascularization (TVR) | Vascular disorders | MedDRA | Systematic Assessment |
|
| Arterial Ulcer | Vascular disorders | MedDRA | Systematic Assessment | Target Leg |
|
| transient ischemic attack (TIA) | Vascular disorders | MedDRA | Systematic Assessment | Transient Ischemic Attack |
|
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| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| Free from MAE |
|
| Title | Measurements |
|---|---|
|
| Acute limb ischemia |
|
| Bleeding event requiring transfusion |
|
| Free from MAVE |
|
| Symptomatic Deep Vein Thrombosis on Ipsilateral Limb |
|
| Title | Measurements |
|---|---|
|
| Freedom from MAE |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Acute Limb Ischemia |
|
| Major Blood Loss Related to the PQ Bypass procedure requiring >2 units or packed RBC |
|
| Symptomatic Deep Vein Thrombosis on Ipsilateral Limb |
|