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The REGAL study is a European, prospective, multi-center Post-Market Clinical Follow-up (PMCF) trial providing additional data including health economics data to support the use of the ELUVIA stent in the treatment of lesions located in the femoropopliteal arteries.
A European, prospective, multi-center Post-Market Clinical Follow-up (PMCF) trial providing additional data including health economics data to support the use of the ELUVIA stent in the treatment of lesions located in the femoropopliteal arteries.
The objective of the study is to collect additional data including health economics data to support the use of the ELUVIA Drug-Eluting Vascular Stent System (ELUVIA Stent) for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ELUVIA stent implantation | Peripheral stenting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peripheral stenting | Device | stent implantation during the index procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant Quality-of-Life Changes Via EuroQol 5 Dimension (EQ-5D) Questionnaire. | The EQ-5D assesses five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) of health-related quality of life responses assigned by the participants. The values are anchored at 1 (best) to 0 (worst). The vales for the visual analog score takes values from 100 (best) to 0 (worst). The index value is comparable across the baseline, 12- and 24-Months timepoints. | Baseline,12 and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Improvement on the Walking Impairment Questionnaire | Improvement was calculated by comparing the scores from 12- and 24-Months to the baseline scores and presenting the number of participants that showed improvement at 12- and 24-Months. The WIQ measures the improvement as reported by participants in their walking distance, walking speed, stair-climbing ability and improvement in their PAD symptoms pre-procedure (baseline) compared to 12 months and compared to 24 months. The improvement at those time points is measured as percent improvement. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Technical Success of the Stenting Procedure | Number of participants that successfully received Eluvia stent. Technical success defined as implanted and achieving residual angiographic stenosis no greater than 30% assessed visually. | During stenting procedure |
| Number of Participants With Procedural Success of the Stenting Procedure |
Inclusion Criteria:
Exclusion Criteria:
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The Intended population for the REGAL study are 'real world'-patients with symptomatic de-novo, restenotic, or (re)occluded lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameter (RVD) ranging from 4.0-6.0 mm, suitable for endovascular treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Carlo Setacci | Policlinico Le Scotte, Siena | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Graz | Graz | Austria | ||||
| ZOL Genk |
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291 participants were enrolled and implanted with the Eluvia Stent
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| ID | Title | Description |
|---|---|---|
| FG000 | ELUVIA Drug-Eluting Vascular Stent System | Peripheral stenting of superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 8, 2016 | Aug 3, 2023 |
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| 12 and 24 months |
| Number of Participants With Improved Rutherford Classification Indicating Rate of Primary and Secondary Sustained Clinical Improvement | The Rutherford Classification describes the different stages of peripheral artery disease (PAD) from a score of 0 (no PAD) to 6 (critical limb ischemia with major tissue loss). The percentages represent the percent of participants that had sustained clinical improvement from baseline to 12 months and baseline to 24 months. Sustained clinical improvement means their Rutherford Class improved by one or more categories compared with baseline. Number of participants with improved Rutherford Classification at 12- and 24-Months when compared to baseline. Primary Sustained Clinical Improvement is improvement in Rutherford Classification of one or more categories as compared to baseline without the need for repeat target lesion revascularization (TLR). Secondary Sustained Clinical Improvement is improvement in Rutherford classification of one or more categories as compared to baseline including those participants with repeat TLR. | 12 and 24 months |
| Number of Participants With Hemodynamic Improvement | Number of participants with improvement in Ankle-Brachial Index (ABI) at 12- and 24-Months compared to baseline. Hemodynamic Improvement is defined as an increase in ABI of >= 0.10 or to an ABI >= 0.90 as compared to baseline without the need for repeat TLR. The ABI measures the arterial pressure in the leg compared to the arterial pressure in the arm. The higher the value, the better the blood flow. Improvement is defined as an increase in the ABI by greater than or equal to 0.10 compared with baseline or to an ABI greater than or equal to 0.90. The percentages in the table represent the patients that demonstrated an improvement in their ABI from baseline to 12 months and baseline to 24-months. | 12 and 24 months |
| Health Care Utilization | Changes in healthcare utilization over time | 1, 6, 12 and 24 months |
Number of participants with successful procedures. Procedural success defined as technical success with no major adverse events (MAEs) noted within 24 hours of the stenting procedure. |
| within 24 hours of stenting procedure |
| Number of Participants With a Major Adverse Event (MAE) | Number of participants with Clinical Events Committee (CEC) adjudicated MAEs at 12- and 24-Months cumulatively. The MAEs are defined as all causes of death, target limb major amputation and/or Target Lesion Revascularization rate. A participant can be present in more than one sub-category. | 12 and 24 months |
| Percentage of Participants With Primary Patency at 12- and 24-Months Post Procedure | The numbers represent the percentage of patients that were event free at 12 and 24 months (i.e. didn't have a TLR). | 12 and 24 months |
| Number of Participants With a Clinically-driven Target Lesion Revascularization (TLR) | The cumulative number of participants that received a clinically-driven target lesion revascularization after the stenting procedure. | 12 and 24 months |
| Number of Participants With a Clinically-driven Target Vessel Revascularization (TVR) | The cumulative number of participants that received a clinically-driven target vessel revascularization after the stenting procedure. | 12 and 24 months |
| Participant Distribution on the Rutherford Classification at Baseline, 12-, and 24- Month | Rutherford Classification: 0. Asymptomatic - Normal Treadmill /stress test
| Baseline, 12 and 24 months |
| Genk |
| Limburg |
| 3600 |
| Belgium |
| Regionaal Ziekenhuis Heilig Hart Tienen | Tienen | Vlaams-Brabant | 3300 | Belgium |
| CHU Sart Tilman | Liège | Belgium |
| Centre Hospitalier Universitaire Grenoble-Alpes | Grenoble | France |
| Clinique Parly II | Le Chesnay | 78150 | France |
| ASL Asti | Asti | 14100 | Italy |
| Policlinico Vittorio Emanuele | Catania | Italy |
| Policlinico di Monza | Monza | Italy |
| Policlinico Umberto I | Roma | 00161 | Italy |
| L'Azienda sanitaira ASL Roma 1 | Roma | 00193 | Italy |
| IRCCS Policlinico San Donato | San Donato Milanese | Italy |
| Hospital Azienda Ospedaliera Universitaria Senese | Siena | 53100 | Italy |
| Hospital Universitario de Burgos | Burgos | 09006 | Spain |
| Hosp. Puerta del Mar | Cadiz | Spain |
| Hospital San Pedro de Alcántara | Cáceres | 10004 | Spain |
| Hosp . Universitario de Guadalajara | Guadalajara | 19002 | Spain |
| Hosp. Ntra Sra. del Rosario | Madrid | 28006 | Spain |
| Hospital Clinico San Carlos | Madrid | 28040 | Spain |
| Hosp. Complejo Hosp Universitario (CHUO) | Ourense | Spain |
| Hospital de Montecelo (Pontevedra EOXI) | Pontevedra | 30071 | Spain |
| Hospital Parc Tauli | Sabadell | Spain |
| Foundation for the Aragonese Healthcare Research Institute | Zaragoza | 50009 | Spain |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ELUVIA Drug-Eluting Vascular Stent System | Peripheral stenting of superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
| ||||||||||||||||||
| Smoking Status | Count of Participants | Participants |
| ||||||||||||||||||
| Current Diabetes Mellitus | Count of Participants | Participants |
| ||||||||||||||||||
| History of Hyperlipidemia requiring medication | Count of Participants | Participants |
| ||||||||||||||||||
| History of Hypertension requiring medication | Count of Participants | Participants |
| ||||||||||||||||||
| History of Chronic Obstructive Pulmonary Disease | Count of Participants | Participants |
| ||||||||||||||||||
| Cardiac history | Count of Participants | Participants |
| ||||||||||||||||||
| New York Heat Assoc. (NHYA) Classification | Participants utilized the NHYA Scale if they were diagnosed with symptomatic heart Failure (stage D). The classes are scored from varying difficulty of activity from class I (best) to class IV( worst) | Not all subjects had this comorbidity | Count of Participants | Participants |
| ||||||||||||||||
| Current Anginal Status | Count of Participants | Participants |
| ||||||||||||||||||
| History of Renal Insufficiency | Count of Participants | Participants |
| ||||||||||||||||||
| History of Peripheral Vascular Disease | Count of Participants | Participants |
| ||||||||||||||||||
| History of Endovascular Interventions in Target Vessel | Count of Participants | Participants |
| ||||||||||||||||||
| Target Lesion Length | Mean | Standard Deviation | mm |
| |||||||||||||||||
| Chronic Total Occlusion | 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 | Participant Quality-of-Life Changes Via EuroQol 5 Dimension (EQ-5D) Questionnaire. | The EQ-5D assesses five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) of health-related quality of life responses assigned by the participants. The values are anchored at 1 (best) to 0 (worst). The vales for the visual analog score takes values from 100 (best) to 0 (worst). The index value is comparable across the baseline, 12- and 24-Months timepoints. | The number analyzed for each row is based on the number of participants that completed the assessment during the specified visit. | Posted | Mean | Standard Deviation | score on a scale | Baseline,12 and 24 months |
|
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Improvement on the Walking Impairment Questionnaire | Improvement was calculated by comparing the scores from 12- and 24-Months to the baseline scores and presenting the number of participants that showed improvement at 12- and 24-Months. The WIQ measures the improvement as reported by participants in their walking distance, walking speed, stair-climbing ability and improvement in their PAD symptoms pre-procedure (baseline) compared to 12 months and compared to 24 months. The improvement at those time points is measured as percent improvement. | The number analyzed for each row is based on the number of participants that completed the assessment during the specified visit. | Posted | Count of Participants | Participants | 12 and 24 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Improved Rutherford Classification Indicating Rate of Primary and Secondary Sustained Clinical Improvement | The Rutherford Classification describes the different stages of peripheral artery disease (PAD) from a score of 0 (no PAD) to 6 (critical limb ischemia with major tissue loss). The percentages represent the percent of participants that had sustained clinical improvement from baseline to 12 months and baseline to 24 months. Sustained clinical improvement means their Rutherford Class improved by one or more categories compared with baseline. Number of participants with improved Rutherford Classification at 12- and 24-Months when compared to baseline. Primary Sustained Clinical Improvement is improvement in Rutherford Classification of one or more categories as compared to baseline without the need for repeat target lesion revascularization (TLR). Secondary Sustained Clinical Improvement is improvement in Rutherford classification of one or more categories as compared to baseline including those participants with repeat TLR. | The number analyzed for each row is based on the number of participants that completed the assessment during the specified visit. | Posted | Count of Participants | Participants | 12 and 24 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Hemodynamic Improvement | Number of participants with improvement in Ankle-Brachial Index (ABI) at 12- and 24-Months compared to baseline. Hemodynamic Improvement is defined as an increase in ABI of >= 0.10 or to an ABI >= 0.90 as compared to baseline without the need for repeat TLR. The ABI measures the arterial pressure in the leg compared to the arterial pressure in the arm. The higher the value, the better the blood flow. Improvement is defined as an increase in the ABI by greater than or equal to 0.10 compared with baseline or to an ABI greater than or equal to 0.90. The percentages in the table represent the patients that demonstrated an improvement in their ABI from baseline to 12 months and baseline to 24-months. | The number analyzed for each row is based on the number of participants that completed the assessment during the specified visit. | Posted | Count of Participants | Participants | 12 and 24 months |
|
| |||||||||||||||||||||||||||||
| Secondary | Health Care Utilization | Changes in healthcare utilization over time | Not Posted | 1, 6, 12 and 24 months | Participants | |||||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Technical Success of the Stenting Procedure | Number of participants that successfully received Eluvia stent. Technical success defined as implanted and achieving residual angiographic stenosis no greater than 30% assessed visually. | Posted | Count of Participants | Participants | During stenting procedure |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With Procedural Success of the Stenting Procedure | Number of participants with successful procedures. Procedural success defined as technical success with no major adverse events (MAEs) noted within 24 hours of the stenting procedure. | Posted | Count of Participants | Participants | within 24 hours of stenting procedure |
|
| ||||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With a Major Adverse Event (MAE) | Number of participants with Clinical Events Committee (CEC) adjudicated MAEs at 12- and 24-Months cumulatively. The MAEs are defined as all causes of death, target limb major amputation and/or Target Lesion Revascularization rate. A participant can be present in more than one sub-category. | Denominators for the cumulative rate is based on 1) participants with events, and 2) participants with no events but their follow-up time reach on (or beyond) the earliest visit window. | Posted | Count of Participants | Participants | 12 and 24 months |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Percentage of Participants With Primary Patency at 12- and 24-Months Post Procedure | The numbers represent the percentage of patients that were event free at 12 and 24 months (i.e. didn't have a TLR). | Analysis utilized a Kaplan-Meier for calculation. The count of participants is estimated from the number of participants and the primary patency rate at 12 Months and 24 Months. | Posted | Count of Participants | Participants | 12 and 24 months |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With a Clinically-driven Target Lesion Revascularization (TLR) | The cumulative number of participants that received a clinically-driven target lesion revascularization after the stenting procedure. | Denominators for the cumulative rate will be based on 1) participants with events, and 2) participants with no events but their follow-up time reach on (or beyond) the earliest visit window. | Posted | Count of Participants | Participants | 12 and 24 months |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Number of Participants With a Clinically-driven Target Vessel Revascularization (TVR) | The cumulative number of participants that received a clinically-driven target vessel revascularization after the stenting procedure. | Denominators for the cumulative rate will be based on 1) participants with events, and 2) participants with no events but their follow-up time reach on (or beyond) the earliest visit window. | Posted | Count of Participants | Participants | 12 and 24 months |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | Participant Distribution on the Rutherford Classification at Baseline, 12-, and 24- Month | Rutherford Classification: 0. Asymptomatic - Normal Treadmill /stress test
| The number analyzed for each timepoint is based on the number of participants that completed the assessment during the specified visit. | Posted | Count of Participants | Participants | Baseline, 12 and 24 months |
|
|
Major Adverse Events (all cause death, major amputation, and TLR) were collected through 24-months of follow-up.
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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 | ELUVIA Drug-Eluting Vascular Stent System | Peripheral stenting of superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions | 28 | 291 | 87 | 291 | 22 | 291 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Bacteriemia | Infections and infestations | Systematic Assessment |
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| Cardiac Failure | Cardiac disorders | Systematic Assessment |
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| Cerebrovascular Accident | Nervous system disorders | Systematic Assessment |
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| Death (Unknown) | General disorders | Systematic Assessment |
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| Gangrene | Vascular disorders | Systematic Assessment |
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| Intestinal Ischemia | Gastrointestinal disorders | Systematic Assessment |
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| Extremity Necrosis | Vascular disorders | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | Systematic Assessment |
| ||
| Post Procedural Complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Peripheral Arterial Occlusive Disease | Vascular disorders | Systematic Assessment |
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| Peripheral Artery Occlusion | Vascular disorders | Systematic Assessment |
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| Artery Dissection | Vascular disorders | Systematic Assessment |
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| Peripheral Artery Stenosis | Vascular disorders | Systematic Assessment |
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| Peripheral Ischemia | Vascular disorders | Systematic Assessment |
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| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Rectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Insufficiency | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Vascular Stent Thrombosis | General disorders | Systematic Assessment |
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| Vascular Stent Occlusion | General disorders | Systematic Assessment |
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| Vascular Stent Stenosis | General disorders | Systematic Assessment |
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| Wound Infection | Infections and infestations | Systematic Assessment |
| ||
| COVID-19 Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Stent Stenosis | General disorders | Systematic Assessment |
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| Stent Restenosis | General disorders | Systematic Assessment |
| ||
| Vascular Pseudoaneurysm | Vascular disorders | Systematic Assessment |
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| Vascular Disorders | Vascular disorders | Systematic Assessment |
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| Arterial Disorder | Vascular disorders | Systematic Assessment |
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| Arterial Restenosis | Vascular disorders | Systematic Assessment |
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| Dry Gangrene | Vascular disorders | Systematic Assessment |
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| Peripheral Artery Restenosis | Vascular disorders | Systematic Assessment |
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| Toe Amputation | Surgical and medical procedures | Systematic Assessment |
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| Foot Amputation | Surgical and medical procedures | Systematic Assessment |
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| Leg Amputation | Surgical and medical procedures | Systematic Assessment |
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| Finger Amputation | Surgical and medical procedures | Systematic Assessment |
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| Limb Amputation | Surgical and medical procedures | Systematic Assessment |
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| Diabetic Foot Infection | Infections and infestations | Systematic Assessment |
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| Septic Shock | Infections and infestations | Systematic Assessment |
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| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
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| Arrhythmia | Cardiac disorders | Systematic Assessment |
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| Cardiopulmonary failure | Cardiac disorders | Systematic Assessment |
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| Renal Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Blood creatinine increased | Investigations | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Wound | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Arterial Puncture | Surgical and medical procedures | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haematoma | Vascular disorders | Systematic Assessment |
| ||
| Extremity Necrosis | Vascular disorders | Systematic Assessment |
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| Artery Dissection | Vascular disorders | Systematic Assessment |
| ||
| Vascular Stent Stenosis | General disorders | Systematic Assessment |
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| Toe Amputation | Surgical and medical procedures | Systematic Assessment |
| ||
| Vascular Pseudoaneurysm | Vascular disorders | Systematic Assessment |
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| Vascular Stent Occlusion | General disorders | Systematic Assessment |
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| Vascular Stent Thrombosis | General disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bryan Arebalo | Boston Scientific | +1 949-241-4300 | bryan.arebalo@bsci.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 4, 2022 | Aug 3, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001157 | Arterial Occlusive Diseases |
| D050197 | Atherosclerosis |
| D014652 | Vascular Diseases |
| D001161 | Arteriosclerosis |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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|
| Black of African heritage |
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| Caucasian |
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| Hispanic or Latino |
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| Native Hawaiian or other Pacific Islander |
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| Other |
|
| Not disclosed |
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| France |
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| Spain |
|
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| Previous |
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| Unknown |
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| History of congestive heart failure |
|
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| Class II |
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| Class III |
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| Class IV |
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| Unknown |
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| Unstable angina |
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| Unknown |
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| 24-month Index Value |
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| Baseline - Visual Analogue Scale |
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| 12-month - Visual Analogue Scale |
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| 24-month - Visual Analogue Scale |
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| Counts |
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| Participants |
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