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To demonstrate the patency and safety of vascular grafts: EXXCEL and FUSION Bioline.
The study is a prospective, randomized, single-blind, two-arm, parallel group, multi-center study to evaluate the safety and efficacy of FUSION™ Vascular Graft with Bioline (heparin) coating, compared with EXXCEL Soft ePTFE in a peripheral bypass setting, to support a claim of substantial equivalence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXXCEL Soft | Active Comparator | A vascular graft comprised of extruded, expanded polytetrafluroethylene (ePTFE), indicated for use as a vascular prosthesis for replacement or bypass of diseased peripheral arteries (510(k) K962433). |
|
| FUSION Bioline | Experimental | A synthetic vascular graft constructed of two layers. The inner layer is comprised of extruded, ePTFE. The outer layer is comprised of knit polyester textile. These two layers are fused together with a proprietary polycarbonate-urethane adhesive. The vascular graft also has a heparin coating on the graft's luminal surface. The Bioline coating is a bioactive surface coating consisting of a covalent Heparin Sodium coupled to immobilized recombinant human albumin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| vascular grafts | Device | All devices will be used to treat patients with peripheral arterial occlusive disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Primary Patency | A graft was considered to have primary patency if it had remained continuously patent (i.e., had continued blood flow through it) from the time of implantation and it had uninterrupted patency with no procedure performed on it, nor a procedure to address disease progression in the adjacent native vessel. Stenosis developing within the graft without remediation or occlusion was not considered a loss of primary patency. Assessed by duplex ultrasound imaging and ankle brachial index (ABI). | 6 months |
| The Number of Participants Meeting Composite Endpoint of Major Adverse Limb Events (MALE) and Periprocedural Death (POD) | The composite endpoint included any of the following:
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Primary Assisted Patency | Primary assisted patency was defined as continued patency without thrombosis, with or without an endovascular or open surgical intervention to remediate a stenosis or other disorder of the graft. | 6 months |
| Number of Participants With Secondary Patency |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Primary Patency | A graft was considered to have primary patency if it had remained continuously patent (i.e., had continued blood flow through it) from the time of implantation and it had uninterrupted patency with no procedure performed on it, nor a procedure to address disease progression in the adjacent native vessel. Stenosis developing within the graft without remediation or occlusion was not considered a loss of primary patency. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Lumsden, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Nicholas J. Morrissey, MD | NY Presbyterian-Columbia U Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama-Birmingham Medical Center | Birmingham | Alabama | 35294 | United States | ||
| Central Arkansas Veterans Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25720929 | Background | Lumsden AB, Morrissey NJ; Comparison of Safety and Primary Patency Between the FUSION BIOLINE Heparin-Coated Vascular Graft and EXXCEL Soft ePTFE (FINEST) Trial Co-investigators. Randomized controlled trial comparing the safety and efficacy between the FUSION BIOLINE heparin-coated vascular graft and the standard expanded polytetrafluoroethylene graft for femoropopliteal bypass. J Vasc Surg. 2015 Mar;61(3):703-12.e1. doi: 10.1016/j.jvs.2014.10.008. | |
| 41159585 |
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Subjects (209) were randomly assigned to FUSION Bioline (108) or EXXCEL (101) - 2 subjects in the FUSION Bioline group did not undergo surgery and are excluded from all analysis. One (1) of 207 treated subjects was included in efficacy analysis but excluded from safety analysis due to wrong treatment (FUSION instead of FUSION Bioline implanted).
Recruitment period was from May 2010 to June 2012 at 18 sites in the United States (US) and 7 sites outside the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | EXXCEL Soft | Patients who were enrolled and treated with the EXXCEL Soft vascular graft. |
| FG001 | FUSION Bioline | Patients who were enrolled and treated with the FUSION Bioline vascular graft. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
This was a prospective, randomized, single-blind (subject), parallel group, multicenter study in subjects with peripheral arterial occlusive disease (PAOD) who were scheduled to undergo femoral popliteal peripheral bypass surgery. Eligible subjects were randomly assigned in a 1:1 ratio to receive either FUSION Bioline or EXXCEL vascular graft.
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This was a single-blind study. The surgeon and study site staff knew which vascular graft each subject received, but the subject did not.
Secondary patency was defined as patency after some form of intervention to restore and maintain blood flow after occlusion. |
| 6 months |
| Time to Hemostasis of Suture Hole Bleeding (Min) | Time from the release of clamps until hemostasis, where hemostasis is defined as the absence of detectable bleeding from any of the suture holes. | Post-procedure |
| 30 days |
| Number of Participants With Primary Patency | A graft was considered to have primary patency if it had remained continuously patent (i.e., had continued blood flow through it) from the time of implantation and it had uninterrupted patency with no procedure performed on it, nor a procedure to address disease progression in the adjacent native vessel. Stenosis developing within the graft without remediation or occlusion was not considered a loss of primary patency. | 12 months |
| Number of Participants With Primary Assisted Patency | Primary assisted patency was defined as continued patency without thrombosis, with or without an endovascular or open surgical intervention to remediate a stenosis or other disorder of the graft. | 30 days |
| Number of Participants With Primary Assisted Patency | Primary assisted patency was defined as continued patency without thrombosis, with or without an endovascular or open surgical intervention to remediate a stenosis or other disorder of the graft. | 12 months |
| Number of Participants With Secondary Patency | Secondary patency was defined as patency after some form of intervention to restore and maintain blood flow after occlusion. | 30 days |
| Number of Participants With Secondary Patency | Secondary patency was defined as patency after some form of intervention to restore and maintain blood flow after occlusion. | 12 months |
| Little Rock |
| Arkansas |
| 72205 |
| United States |
| VA Palo Alto HCS | Palo Alto | California | 94304 | United States |
| University of South Florida - Tampa General | Tampa | Florida | 33606 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Dartmouth- Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| NYU School of Medicine | New York | New York | 10016 | United States |
| NY Presbyterian Hospital - Columbia Univ Medical Center | New York | New York | 10032 | United States |
| Montefiore Weiler Hospital | The Bronx | New York | 10461 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Dallas VA Medical Center | Dallas | Texas | 75216 | United States |
| Methodist Hospital | Houston | Texas | 77030 | United States |
| Central Texas Veterans Health System | Temple | Texas | 76504 | United States |
| Scott & White | Temple | Texas | 76508 | United States |
| Norfolk Sentara - Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| Swedish Medical Center | Seattle | Washington | 98122 | United States |
| Fakulti Nemocnice Brno | Brno | 625 00 | Czechia |
| Fakultni Nemocnice u sv Anny v Brno | Brno | 656 91 | Czechia |
| University Hospital Plzen | Pilsen | 304 60 | Czechia |
| Vseobecna Fakultni Nemocnice (VFN) Praha | Prague | 128 08 | Czechia |
| IKEM Praha | Prague | 140 21 | Czechia |
| Nemocnice Na Homolce | Prague | 150 30 | Czechia |
| Klinikum Karlsruhe | Karlsruhe | 76133 | Germany |
| Derived |
| Correia RM, Nakano LC, Vasconcelos V, Cristino MA, Flumignan RL. Prevention of infection in peripheral arterial reconstruction of the lower limb. Cochrane Database Syst Rev. 2025 Oct 29;10(10):CD015022. doi: 10.1002/14651858.CD015022.pub2. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Of the 207 subjects treated, 203 were included in the efficacy analysis population. Four subjects were excluded due to data being unavailable for analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | EXXCEL Soft | Patients who were enrolled and treated with the EXXCEL Soft vascular graft. |
| BG001 | FUSION Bioline | Patients who were enrolled and treated with the FUSION Bioline vascular graft. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||||
| Body Mass Index (BMI) | Body mass index calculation based upon weight (in kg) divided by the height (in meters) squared. | Mean | Standard Deviation | kg/m^2 |
| ||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||||
| Rutherford Category | Count of Participants | Participants |
| ||||||||||||||||||
| Ankle Brachial Index (ABI) | The ankle brachial index (ABI) is the ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm. | Mean | Standard Deviation | Ratio |
| ||||||||||||||||
| Baseline medications | Count of Participants | Participants |
| ||||||||||||||||||
| Comorbidities | Count of Participants | Participants |
| ||||||||||||||||||
| Tobacco use | Count of Participants | Participants |
| ||||||||||||||||||
| Graft diameter | Count of Participants | Participants |
| ||||||||||||||||||
| Leg treated | Count of Participants | Participants |
| ||||||||||||||||||
| Site of proximal anastomosis | Count of Participants | Participants |
| ||||||||||||||||||
| Site of distal anastomosis | Count of Participants | Participants |
|
| 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 Participants With Primary Patency | A graft was considered to have primary patency if it had remained continuously patent (i.e., had continued blood flow through it) from the time of implantation and it had uninterrupted patency with no procedure performed on it, nor a procedure to address disease progression in the adjacent native vessel. Stenosis developing within the graft without remediation or occlusion was not considered a loss of primary patency. Assessed by duplex ultrasound imaging and ankle brachial index (ABI). | Subset of the efficacy analysis population with available data for analysis. The efficacy analysis population included all randomized subjects who met a study endpoint at 6 months. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | The Number of Participants Meeting Composite Endpoint of Major Adverse Limb Events (MALE) and Periprocedural Death (POD) | The composite endpoint included any of the following:
| Safety population, defined as all randomized subjects who received the FUSION Bioline or EXXCEL vascular graft, analyzed according to the treatment they received. | Posted | Count of Participants | Participants | 6 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Primary Assisted Patency | Primary assisted patency was defined as continued patency without thrombosis, with or without an endovascular or open surgical intervention to remediate a stenosis or other disorder of the graft. | Subset of the efficacy analysis population with available data for analysis. The efficacy analysis population included all randomized subjects who met a study endpoint at 6 months. | Posted | Count of Participants | Participants | 6 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Secondary Patency | Secondary patency was defined as patency after some form of intervention to restore and maintain blood flow after occlusion. | Subset of the efficacy analysis population with available data for analysis. The efficacy analysis population included all randomized subjects who met a study endpoint at 6 months. | Posted | Count of Participants | Participants | 6 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Hemostasis of Suture Hole Bleeding (Min) | Time from the release of clamps until hemostasis, where hemostasis is defined as the absence of detectable bleeding from any of the suture holes. | Subset of the efficacy analysis population with available data for analysis. The efficacy analysis population included all randomized subjects who met a study endpoint at 6 months. | Posted | Mean | Standard Deviation | minutes | Post-procedure |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Primary Patency | A graft was considered to have primary patency if it had remained continuously patent (i.e., had continued blood flow through it) from the time of implantation and it had uninterrupted patency with no procedure performed on it, nor a procedure to address disease progression in the adjacent native vessel. Stenosis developing within the graft without remediation or occlusion was not considered a loss of primary patency. | Subset of the efficacy analysis population with available data for analysis. The efficacy analysis population included all randomized subjects who met a study endpoint at 6 months. | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Primary Patency | A graft was considered to have primary patency if it had remained continuously patent (i.e., had continued blood flow through it) from the time of implantation and it had uninterrupted patency with no procedure performed on it, nor a procedure to address disease progression in the adjacent native vessel. Stenosis developing within the graft without remediation or occlusion was not considered a loss of primary patency. | Subset of the efficacy analysis population with available data for analysis. The efficacy analysis population included all randomized subjects who met a study endpoint at 6 months. The 12 month efficacy analysis population for the 12 month results included those subjects who met the study endpoint at both 6 and 12 months. | Posted | Count of Participants | Participants | 12 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Primary Assisted Patency | Primary assisted patency was defined as continued patency without thrombosis, with or without an endovascular or open surgical intervention to remediate a stenosis or other disorder of the graft. | Subset of the efficacy analysis population with available data for analysis. The efficacy analysis population included all randomized subjects who met a study endpoint at 6 months. | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Primary Assisted Patency | Primary assisted patency was defined as continued patency without thrombosis, with or without an endovascular or open surgical intervention to remediate a stenosis or other disorder of the graft. | Subset of the efficacy analysis population with available data for analysis. The efficacy analysis population included all randomized subjects who met a study endpoint at 6 months. The 12 month efficacy analysis population for the 12 month results included those subjects who met the study endpoint at both 6 and 12 months. | Posted | Count of Participants | Participants | 12 months |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Secondary Patency | Secondary patency was defined as patency after some form of intervention to restore and maintain blood flow after occlusion. | Subset of the efficacy analysis population with available data for analysis. The efficacy analysis population included all randomized subjects who met a study endpoint at 6 months. | Posted | Count of Participants | Participants | 30 days |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Secondary Patency | Secondary patency was defined as patency after some form of intervention to restore and maintain blood flow after occlusion. | Subset of the efficacy analysis population with available data for analysis. The efficacy analysis population included all randomized subjects who met a study endpoint at 6 months. The 12 month efficacy analysis population for the 12 month results included those subjects who met the study endpoint at both 6 and 12 months. | Posted | Count of Participants | Participants | 12 months |
|
|
One Year
An adverse event was defined as any side effect associated with the treatment procedure or device that produced an untoward medical effect or that had adverse health implications for the subject receiving the treatment. Adverse event data were collected from the time of procedure start through the last follow-up visit. Note that one (1) of 207 treated subjects was included in efficacy analysis but excluded from safety analysis due to wrong treatment (FUSION instead of FUSION Bioline implanted).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EXXCEL Soft | Patients who were enrolled and treated with the EXXCEL Soft vascular graft. The safety population was defined as all randomized subjects who received the FUSION Bioline or EXXCEL vascular graft, analyzed according to the treatment they received. | 2 | 101 | 50 | 101 | 14 | 101 |
| EG001 | FUSION Bioline | Patients who were enrolled and treated with the FUSION Bioline vascular graft. The safety population was defined as all randomized subjects who received the FUSION Bioline or EXXCEL vascular graft, analyzed according to the treatment they received. Note that one patient was randomized to the Fusion Bioline group but received the FUSION graft in error. | 4 | 105 | 44 | 105 | 24 | 105 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vascular graft thrombosis / Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Anastomotic stenosis | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Graft haemorrhage | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Lumbar vertebral fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Post procedural myocardial infarction | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Vascular graft complication | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Vascular procedure complication | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Graft infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Haematoma infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection enterococcal | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Wound infection pseudomonas | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Femoral arterial stenosis | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Arterial stenosis limb | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Lymphocele | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Peripheral artery dissection | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Implant site effusion | General disorders | MedDRA | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA | Non-systematic Assessment |
| |
| Hernia obstructive | General disorders | MedDRA | Non-systematic Assessment |
| |
| Medical device complication | General disorders | MedDRA | Non-systematic Assessment |
| |
| Arterial bypass operation | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Foot amputation | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Carotid endarterectomy | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Debridement | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Peripheral artery angioplasty | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Skin graft | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Toe amputation | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Embolic stroke | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Retroperitoneal haematoma | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Psychiatric decompensation | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Soft tissue necrosis | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
| |
| Penile oedema | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Non-systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA | Non-systematic Assessment |
|
Follow-up period was limited to 12 months. The inner layer is identical to EXXCEL, but FUSION Bioline also has an external polyester layer in addition to the heparin coating. Choices in perioperative care (surgeon discretion) may have differed.
The publication or presentation of the results from a single site was not allowed until the preparation and publication of the multi-center results. Individual sites could publish or present information, provided that a draft was given to the sponsor for review and comment for a period that is at least 60 days prior to the first date of submission to allow the sponsor to review its content for accuracy, confidential information or patentable inventions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Bulger | Getinge Group | 603 880 1433 | 5368 | Elizabeth.Bulger@getinge.com |
| ID | Term |
|---|---|
| C564658 | Peripheral Arterial Occlusive Disease 1 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D058017 | Vascular Grafting |
| ID | Term |
|---|---|
| D014656 | Vascular Surgical Procedures |
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| African American |
|
| Hispanic |
|
| Asian |
|
| Other |
|
| Czechia |
|
| Germany |
|
| 4-5 (limb threat) |
|
| Clopidogrel |
|
| Any antiplatelet |
|
| Warfarin |
|
| Statin |
|
| Angiotensin-converting enzyme (ACE) inhibitor |
|
| Hyperlipidemia/hypercholesterolemia |
|
| Hypertension |
|
| Coronary artery disease |
|
| Obesity |
|
| Chronic obstructive lung disease |
|
| Cerebrovascular event |
|
| Liver disease |
|
| Bleeding disorder |
|
| Renal failure/dysfunction |
|
| Diabetes mellitus |
|
| Previous myocardial infarction |
|
| Arrhythmia |
|
| Congestive heart failure |
|
| Varicose veins |
|
| Prior smoker |
|
| Non-smoker |
|
| 8 mm |
|
| Left |
|
| Common femoral |
|
| Profunda femoral |
|
| Superficial femoral |
|
| Other |
|
| Below knee |
|
| Other |
|
| Non-Inferiority |
The non-inferiority margin was 15%. The following null hypothesis (H0) and alternative hypothesis (HA) were tested, with the primary patency rate at 6 months for FUSION Bioline (PF), and the primary patency rate at 6 months for EXXCEL (PE). H0: PF - PE < - 0.15; HA: PF - PE > - 0.15 An exact 1-sided test was used for the observed difference of patency rates between the FUSION Bioline (test) and EXXCEL (control) products. |
| Participants |
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