Peripheral Arterial Disease
Conditions
Keywords
PAD, PVD, SFA stent
Brief summary
The MIMICS-3D study will evaluate safety, effectiveness and device performance within a real-world clinical population of patients undergoing femoropopliteal intervention.
Detailed description
The MIMICS-3D study is a prospective, multicentre, observational study of the BioMimics 3D Stent System in patients undergoing endovascular intervention to relieve symptomatic peripheral arterial disease of the femoropopliteal artery. The study is designed to enable the collection, analysis and reporting of data from real-world use of the BioMimics 3D Stent System used in accordance with the Instructions for Use (IFU) associated with the product's CE Mark approval. Data collection will include that relating to safety, effectiveness and device performance and the period of observation during which data will be collected will extend from the index procedure through 3 years (36 months), according to the standard follow-up practice of the enrolling institution.
Interventions
DEVICEBioMimics 3D Stent
Sponsors
Veryan Medical Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Patient is age ≥18 and ≤85 years at date of consent. * Patient has provided written informed consent for participation in the study prior to index procedure. * Patient has documented symptomatic peripheral arterial disease scheduled for treatment with the BioMimics 3D stent in accordance with the approved CE Mark indication and Instructions for Use (IFU)
Exclusion criteria
* Patients whose lesions cannot be crossed with a wire and/or balloon catheter and cannot be dilated sufficiently to allow passage of the delivery system. * Patients with a history of intolerance or adverse reaction to antiplatelet and/or anticoagulation therapies, bleeding diathesis, severe hypertension or renal failure. * Patients with known hypersensitivity to nickel-titanium. * Patient has a comorbidity that in the Investigator's opinion would limit life expectancy to less than 12 months. * Patient is pregnant or breastfeeding. * Patient is unable or is unwilling to comply with site standard of care procedures and follow-up visit schedules for patients undergoing femoropopliteal intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Free From Major Adverse Events (MAE) | 30 days | Primary Safety Endpoint: Number of participants free from a composite of major adverse events (MAE) comprising death, any major amputation performed on the index limb or clinically-driven target lesion revascularization (CDTLR) through 30 days. |
| Number of Participants Free From Clinically-driven Target Lesion Revascularization (CDTLR) | 12 months | Primary Effectiveness Endpoint: Number of participants free from clinically-driven target lesion revascularization (CDTLR) through 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Probability of Individual Components of MAE | 30 days, 12 Months, and 24 Months. | A Kaplan-Meier (KM) analysis of individual components of MAE (death, any major amputation performed on the index limb or CDTLR) through 24 months. |
| Number of Participants With Adverse Events | 30 day, 12 and 24 months | Overall rate of all adverse events reported from Day 0 through 24 months. An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in participants, whether or not related to the investigational device or procedure. For the purpose of this Study all potentially device-related and procedure-related adverse events, major adverse events (death, major amputation on the target limb, clinically-driven target lesion revascularisation), all vascular adverse events in the target limb, and serious adverse events are reported throughout the Study. |
| Stent Patency Rate | 12 and 24 months. | Per Protocol, patency is defined as the composite of freedom from more than 50% restenosis within the stented segment as observed by Duplex Ultrasound or Angiography within the visit window and freedom from clinically-driven target lesion revascularisation prior to the indicated time point. Stent patency rate assessed by duplex ultrasound (DUS), as available, determined at Months 12 and 24. This will be assessed using values of peak systolic velocity ratio (PSVR) \>2.0, \>2.4; \>2.5; and \>3.5. PSVR values of \>2.0, \>2.4, \>2.5 and \>3.5 were selected to compare outcomes from similar studies. There are no official definitions or guidelines on these values and which are most accurate for detection of \>50% stenosis, so all have been used in the analyses to compare results from other studies. PSVR of \>2.4, was looked at further as there are some studies that state this is the most established threshold for the detection of \>50% stenosis (Schlager, et al. 2007). |
| Number of Participants With a Final Residual Diameter Stenosis ≤30% at the End of the Index Procedure | Within 72 hours of the index procedure. | Acute Technical Success: Number of participants with a final residual diameter stenosis ≤30% within 72 hours of the index procedure. |
| Comparison of Ankle Brachial Index (ABI) Measurement | Baseline, Day 30, 12-month and 24-month. | Functional outcome: Mean and standard deviation of the Ankle Brachial Index at each follow-up visit is reported. The change of Ankle Brachial Index at 30 days, 12 and 24 months compared to Baseline is presented for the total number of patients where data were recorded, and the mean and standard deviation of the change. ABI is the ratio of blood pressure measured at the ankle to blood pressure measured at the arms. It is used to predict the severity of peripheral arterial disease. An ABI of \>0.9-1.2 is considered normal, ≤ 0.9 indicates mild to moderate peripheral arterial disease, \< 0.4 indicates severe peripheral arterial disease (ischemic pain and ulceration). |
| Number of Participants With Reported Stent Fracture | 30 day, 12 and 24 Months. | Site reported number of participants with stent fracture through 24 months. Stent fracture is defined as clear interruption of stent strut observed in a minimum of two projections, determined by examination of X-ray images. Stent Strut Fracture Types: Type 0: No strut fractures. Type I: Single strut fracture only. Type II: Multiple single strut fractures that can occur at different sites. Type III: Multiple strut fractures resulting in complete transection of the stent, without displacement of the stent segments. Type IV: Multiple strut fractures resulting in displacement of segments of the stent. Type V: Spiral strut fracture. |
| Comparison of Rutherford Clinical Category | Baseline, Day 30, 12 months and 24 months | Clinical Outcome: Comparison of Rutherford Clinical Category (RCC) measured at Baseline, Day 30, Months 12 and 24. Rutherford Clinical Category is a clinical scale identifying three grades of claudication (RCC 1-3) and three grades of critical limb ischemia (RCC 4-6) ranging from rest pain alone to minor and major tissue loss. Category and clinical description: 0 - Asymptomatic, 1 - Mild claudication 2 - Moderate claudication, 3 - Severe claudication, 4 - Ischemic rest pain, 5 - Minor tissue loss, 6 - Ulceration or gangrene. |
| Number of Participants With Acute Technical Success and Absence of the Adverse Events Listed in the Description | Within 72 hours of index procedure. | Acute Procedural Success: Number of participants with acute technical success (achievement of a final stenosis ≤30% at the end of the procedure) and absence of the following adverse events: death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and/or need for urgent/emergent vascular surgery, within 72 hours of index procedure. |
Countries
Belgium, Germany, Netherlands, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| BioMimics 3D Stent Implantation of BioMimics 3D nitinol stent onto subjects who receive a treatment in accordance with the current approved CE mark indication for use as stated in the IFU. | 507 |
| Total | 507 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 52 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Missed Visit | 33 |
| Overall Study | Withdrawal by Subject | 20 |
Baseline characteristics
| Characteristic | BioMimics 3D Stent |
|---|---|
| Age, Continuous | 70.1 Years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 507 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 504 Participants |
| Region of Enrollment Belgium | 80 participants |
| Region of Enrollment Germany | 413 participants |
| Region of Enrollment Netherlands | 1 participants |
| Region of Enrollment Sweden | 13 participants |
| Sex: Female, Male Female | 175 Participants |
| Sex: Female, Male Male | 332 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 52 / 507 |
| other Total, other adverse events | 19 / 507 |
| serious Total, serious adverse events | 282 / 507 |
Outcome results
Primary
Number of Participants Free From Clinically-driven Target Lesion Revascularization (CDTLR)
Primary Effectiveness Endpoint: Number of participants free from clinically-driven target lesion revascularization (CDTLR) through 12 months.
Time frame: 12 months
Population: Participants who came for a follow-up visit (12M, 24M, 36M) or any participant who experienced CDTLR ≤ 365 days. Sixty-four (64) participants were ineligible for the primary effectiveness endpoint analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Safety Endpoint | Number of Participants Free From Clinically-driven Target Lesion Revascularization (CDTLR) | 396 Participants |
Primary
Number of Participants Free From Major Adverse Events (MAE)
Primary Safety Endpoint: Number of participants free from a composite of major adverse events (MAE) comprising death, any major amputation performed on the index limb or clinically-driven target lesion revascularization (CDTLR) through 30 days.
Time frame: 30 days
Population: Participants who came for any follow-up visit (30D, 12M, 24M, 36M) or anyone who experienced a MAE ≤30 days. Twelve (12) participants were ineligible for the primary safety endpoint analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Primary Safety Endpoint | Number of Participants Free From Major Adverse Events (MAE) | 30 Days Freedom from MAE | 489 Participants |
| Primary Safety Endpoint | Number of Participants Free From Major Adverse Events (MAE) | 30 Days Freedom from Death | 492 Participants |
| Primary Safety Endpoint | Number of Participants Free From Major Adverse Events (MAE) | 30 Days Freedom from Amputation | 492 Participants |
| Primary Safety Endpoint | Number of Participants Free From Major Adverse Events (MAE) | 30 Days Freedom from CDTLR | 491 Participants |
Secondary
Comparison of Ankle Brachial Index (ABI) Measurement
Functional outcome: Mean and standard deviation of the Ankle Brachial Index at each follow-up visit is reported. The change of Ankle Brachial Index at 30 days, 12 and 24 months compared to Baseline is presented for the total number of patients where data were recorded, and the mean and standard deviation of the change. ABI is the ratio of blood pressure measured at the ankle to blood pressure measured at the arms. It is used to predict the severity of peripheral arterial disease. An ABI of \>0.9-1.2 is considered normal, ≤ 0.9 indicates mild to moderate peripheral arterial disease, \< 0.4 indicates severe peripheral arterial disease (ischemic pain and ulceration).
Time frame: Baseline, Day 30, 12-month and 24-month.
Population: Four-hundred and seventeen (417) participants had their ABI measured at Baseline. Three-hundred and eighty-three (383) participants at Day 30. Three hundred and fifty-nine (359) participants at Month 12. Three-hundred and four participants at Month 24.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Primary Safety Endpoint | Comparison of Ankle Brachial Index (ABI) Measurement | Baseline ABI | 0.6 ABI | Standard Deviation 0.3 |
| Primary Safety Endpoint | Comparison of Ankle Brachial Index (ABI) Measurement | 30 Days ABI | 1.0 ABI | Standard Deviation 0.2 |
| Primary Safety Endpoint | Comparison of Ankle Brachial Index (ABI) Measurement | 12 Months ABI | 0.9 ABI | Standard Deviation 0.2 |
| Primary Safety Endpoint | Comparison of Ankle Brachial Index (ABI) Measurement | 24 Months ABI | 0.9 ABI | Standard Deviation 0.2 |
| Primary Safety Endpoint | Comparison of Ankle Brachial Index (ABI) Measurement | 30 Days Change from Baseline ABI | 0.4 ABI | Standard Deviation 0.3 |
| Primary Safety Endpoint | Comparison of Ankle Brachial Index (ABI) Measurement | 12 Months Change from Baseline ABI | 0.3 ABI | Standard Deviation 0.3 |
| Primary Safety Endpoint | Comparison of Ankle Brachial Index (ABI) Measurement | 24 Months Change from Baseline ABI | 0.3 ABI | Standard Deviation 0.3 |
Secondary
Comparison of Rutherford Clinical Category
Clinical Outcome: Comparison of Rutherford Clinical Category (RCC) measured at Baseline, Day 30, Months 12 and 24. Rutherford Clinical Category is a clinical scale identifying three grades of claudication (RCC 1-3) and three grades of critical limb ischemia (RCC 4-6) ranging from rest pain alone to minor and major tissue loss. Category and clinical description: 0 - Asymptomatic, 1 - Mild claudication 2 - Moderate claudication, 3 - Severe claudication, 4 - Ischemic rest pain, 5 - Minor tissue loss, 6 - Ulceration or gangrene.
Time frame: Baseline, Day 30, 12 months and 24 months
Population: RCC is collected serially over time and is presented at each time point. The measure from each time point is compared to the baseline measure. Three (3) participants did not have a baseline RCC assessed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | Baseline RCC 6 | 11 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | 30 Days RCC 0 | 172 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | 30 Days RCC 1 | 121 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | 30 Days RCC 2 | 62 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | 30 Days RCC 3 | 30 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | 30 Days RCC 4 | 7 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | 30 Days RCC 5 | 30 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | 30 Days RCC 6 | 1 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | 12 Months RCC 0 | 151 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | 12 Months RCC 1 | 121 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | 12 Months RCC 2 | 60 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | 12 Months RCC 3 | 36 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | 12 Months RCC 4 | 4 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | 12 Months RCC 5 | 2 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | 12 Months RCC 6 | 1 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | 24 Months RCC 0 | 130 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | 24 Months RCC 1 | 123 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | 24 Months RCC 2 | 48 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | 24 Months RCC 3 | 38 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | 24 Months RCC 4 | 3 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | 24 Months RCC 5 | 2 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | 24 Months RCC 6 | 1 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | Baseline RCC 1 | 6 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | Baseline RCC 0 | 2 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | Baseline RCC 2 | 86 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | Baseline RCC 3 | 289 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | Baseline RCC 4 | 38 Participants |
| Primary Safety Endpoint | Comparison of Rutherford Clinical Category | Baseline RCC 5 | 72 Participants |
Secondary
Number of Participants With Acute Technical Success and Absence of the Adverse Events Listed in the Description
Acute Procedural Success: Number of participants with acute technical success (achievement of a final stenosis ≤30% at the end of the procedure) and absence of the following adverse events: death, stroke, myocardial infarction, acute onset of limb ischemia, index bypass graft or treated segment thrombosis, and/or need for urgent/emergent vascular surgery, within 72 hours of index procedure.
Time frame: Within 72 hours of index procedure.
Population: All enrolled participants (507) were eligible for acute procedural success analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Safety Endpoint | Number of Participants With Acute Technical Success and Absence of the Adverse Events Listed in the Description | 494 Participants |
Secondary
Number of Participants With Adverse Events
Overall rate of all adverse events reported from Day 0 through 24 months. An adverse event (AE) is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in participants, whether or not related to the investigational device or procedure. For the purpose of this Study all potentially device-related and procedure-related adverse events, major adverse events (death, major amputation on the target limb, clinically-driven target lesion revascularisation), all vascular adverse events in the target limb, and serious adverse events are reported throughout the Study.
Time frame: 30 day, 12 and 24 months
Population: All enrolled participants (507) were eligible for the rate of AE analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Primary Safety Endpoint | Number of Participants With Adverse Events | 30 Day (≤ 37 days) Participant's Overall Adverse Events | 84 Participants |
| Primary Safety Endpoint | Number of Participants With Adverse Events | 30 Day (≤ 37 days) Participant's Overall Device Related Adverse Events | 7 Participants |
| Primary Safety Endpoint | Number of Participants With Adverse Events | 30 Day (≤ 37 days) Participant's Overall Procedure Adverse Events | 36 Participants |
| Primary Safety Endpoint | Number of Participants With Adverse Events | 30 Day (≤ 37 days) Participant's Overall Serious Adverse Events | 60 Participants |
| Primary Safety Endpoint | Number of Participants With Adverse Events | 30 Day (≤ 37 days) Participant's Overall Device Related Serious Adverse Events | 6 Participants |
| Primary Safety Endpoint | Number of Participants With Adverse Events | 30 Day (≤ 37 days) Participant's Overall Procedure Related Serious Adverse Events | 21 Participants |
| Primary Safety Endpoint | Number of Participants With Adverse Events | 12 Month (≤ 395 days) Participant's Overall Adverse Events | 255 Participants |
| Primary Safety Endpoint | Number of Participants With Adverse Events | 12 Month (≤ 395 days) Participant's Overall Device Related Adverse Events | 67 Participants |
| Primary Safety Endpoint | Number of Participants With Adverse Events | 12 Month (≤ 395 days) Participant's Overall Procedure Related Adverse Events | 68 Participants |
| Primary Safety Endpoint | Number of Participants With Adverse Events | 12 Month (≤ 395 days) Participant's Overall Serious Adverse Events | 219 Participants |
| Primary Safety Endpoint | Number of Participants With Adverse Events | 12 Month (≤ 395 days) Participant's Overall Device Related Serious Adverse Events | 59 Participants |
| Primary Safety Endpoint | Number of Participants With Adverse Events | 12 Month (≤ 395 days) Participant's Overall Procedure Related Serious Adverse Events | 44 Participants |
| Primary Safety Endpoint | Number of Participants With Adverse Events | 24 Month (≤ 790 days) Participant's Overall Adverse Events | 318 Participants |
| Primary Safety Endpoint | Number of Participants With Adverse Events | 24 Month (≤ 790 days) Participant's Overall Device Related Adverse Events | 93 Participants |
| Primary Safety Endpoint | Number of Participants With Adverse Events | 24 Month (≤ 790 days) Participant's Overall Procedure Related Adverse Events | 74 Participants |
| Primary Safety Endpoint | Number of Participants With Adverse Events | 24 Month (≤ 790 days) Participant's Overall Serious Adverse Events | 282 Participants |
| Primary Safety Endpoint | Number of Participants With Adverse Events | 24 Month (≤ 790 days) Participant's Overall Device Related Serious Adverse Events | 79 Participants |
| Primary Safety Endpoint | Number of Participants With Adverse Events | 24 Month (≤ 790 days) Participant's Overall Procedure Related Serious Adverse Events | 50 Participants |
Secondary
Number of Participants With a Final Residual Diameter Stenosis ≤30% at the End of the Index Procedure
Acute Technical Success: Number of participants with a final residual diameter stenosis ≤30% within 72 hours of the index procedure.
Time frame: Within 72 hours of the index procedure.
Population: One (1) participant did not have a final diameter stenosis recorded at Index, therefore ineligible for acute technical success analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Safety Endpoint | Number of Participants With a Final Residual Diameter Stenosis ≤30% at the End of the Index Procedure | 501 Participants |
Secondary
Number of Participants With Reported Stent Fracture
Site reported number of participants with stent fracture through 24 months. Stent fracture is defined as clear interruption of stent strut observed in a minimum of two projections, determined by examination of X-ray images. Stent Strut Fracture Types: Type 0: No strut fractures. Type I: Single strut fracture only. Type II: Multiple single strut fractures that can occur at different sites. Type III: Multiple strut fractures resulting in complete transection of the stent, without displacement of the stent segments. Type IV: Multiple strut fractures resulting in displacement of segments of the stent. Type V: Spiral strut fracture.
Time frame: 30 day, 12 and 24 Months.
Population: Four-hundred and eighty-three (483) participants were eligible for this analysis at Day 30; 418 at Month 12; 398 at Month 24. Five (5) participants had X-ray images obtained at Day 30; 5 participants had X-ray images obtained at Month 12; 3 participants had X-ray images obtained at Month 24. In an observational registry x-rays are only conducted if there are clinical symptoms that hint towards a fracture. In the absence of symptoms it is concluded that the subject did not suffer a stent fracture
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Primary Safety Endpoint | Number of Participants With Reported Stent Fracture | Stent Fracture at 30 Days | 0 Participants |
| Primary Safety Endpoint | Number of Participants With Reported Stent Fracture | Stent Fracture at 12 Months | 0 Participants |
| Primary Safety Endpoint | Number of Participants With Reported Stent Fracture | Stent Fracture at 24-Months | 3 Participants |
| Primary Safety Endpoint | Number of Participants With Reported Stent Fracture | Stent Fracture Category Type 0 at 24 Months | 0 Participants |
| Primary Safety Endpoint | Number of Participants With Reported Stent Fracture | Stent Fracture Category Type I at 24 Months | 0 Participants |
| Primary Safety Endpoint | Number of Participants With Reported Stent Fracture | Stent Fracture Category Type II at 24 Months | 3 Participants |
| Primary Safety Endpoint | Number of Participants With Reported Stent Fracture | Stent Fracture Category Type III at 24 Months | 0 Participants |
| Primary Safety Endpoint | Number of Participants With Reported Stent Fracture | Stent Fracture Category Type IV at 24 Months | 0 Participants |
| Primary Safety Endpoint | Number of Participants With Reported Stent Fracture | Stent Fracture Category Type V at 24 Months | 0 Participants |
Secondary
Percent Probability of Individual Components of MAE
A Kaplan-Meier (KM) analysis of individual components of MAE (death, any major amputation performed on the index limb or CDTLR) through 24 months.
Time frame: 30 days, 12 Months, and 24 Months.
Population: All enrolled participants (507) were eligible for KM analysis of MAE.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Safety Endpoint | Percent Probability of Individual Components of MAE | KM analysis of CDTLR at 30 Days % | 0.4 percentage probability |
| Primary Safety Endpoint | Percent Probability of Individual Components of MAE | KM analysis of Death at 30 Days % | 0.4 percentage probability |
| Primary Safety Endpoint | Percent Probability of Individual Components of MAE | KM analysis of Amputation at 30 Days % | 0.4 percentage probability |
| Primary Safety Endpoint | Percent Probability of Individual Components of MAE | KM analysis of Death at 12 Months (Day 360) % | 6.1 percentage probability |
| Primary Safety Endpoint | Percent Probability of Individual Components of MAE | KM analysis of Amputation at 12 Months (Day 360) % | 1.5 percentage probability |
| Primary Safety Endpoint | Percent Probability of Individual Components of MAE | KM analysis of CDTLR at 12 Months (Day 360) % | 9.4 percentage probability |
| Primary Safety Endpoint | Percent Probability of Individual Components of MAE | KM analysis of Death at 24 Months (Day 720) % | 10.4 percentage probability |
| Primary Safety Endpoint | Percent Probability of Individual Components of MAE | KM analysis of Amputation at 24 Months (Day 720) % | 1.5 percentage probability |
| Primary Safety Endpoint | Percent Probability of Individual Components of MAE | KM analysis of CDTLR at 24 Months (Day 720) % | 17.2 percentage probability |
Secondary
Stent Patency Rate
Per Protocol, patency is defined as the composite of freedom from more than 50% restenosis within the stented segment as observed by Duplex Ultrasound or Angiography within the visit window and freedom from clinically-driven target lesion revascularisation prior to the indicated time point. Stent patency rate assessed by duplex ultrasound (DUS), as available, determined at Months 12 and 24. This will be assessed using values of peak systolic velocity ratio (PSVR) \>2.0, \>2.4; \>2.5; and \>3.5. PSVR values of \>2.0, \>2.4, \>2.5 and \>3.5 were selected to compare outcomes from similar studies. There are no official definitions or guidelines on these values and which are most accurate for detection of \>50% stenosis, so all have been used in the analyses to compare results from other studies. PSVR of \>2.4, was looked at further as there are some studies that state this is the most established threshold for the detection of \>50% stenosis (Schlager, et al. 2007).
Time frame: 12 and 24 months.
Population: Number of participants who had patency assessed at month 12 was 443. Number of participants who had patency assessed at month 24 was 409.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Primary Safety Endpoint | Stent Patency Rate | Patency at 12 Months PSVR >2.0 | 370 Participants |
| Primary Safety Endpoint | Stent Patency Rate | Patency at 12 Months PSVR >2.4 | 381 Participants |
| Primary Safety Endpoint | Stent Patency Rate | Patency at 12 Months PSVR >2.5 | 381 Participants |
| Primary Safety Endpoint | Stent Patency Rate | Patency at 12 Months PSVR >3.5 | 388 Participants |
| Primary Safety Endpoint | Stent Patency Rate | Patency at 24 Months PSVR >2.0 | 318 Participants |
| Primary Safety Endpoint | Stent Patency Rate | Patency at 24 Months PSVR >2.4 | 324 Participants |
| Primary Safety Endpoint | Stent Patency Rate | Patency at 24 Months PSVR >2.5 | 324 Participants |
| Primary Safety Endpoint | Stent Patency Rate | Patency at 24 Months PSVR >3.5 | 324 Participants |