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To assess the safety and efficacy of the paclitaxel drug-coated balloon IN.PACT 014 versus conventional optimal percutaneous transluminal angioplasty (PTA) for the treatment of patients with chronic total occlusions in the infrapopliteal arteries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug Coated Balloon IN.PACT 014 (DCB) | Experimental | Participants who receive IN.PACT 014. |
|
| Percutaneous Transluminal Angioplasty (PTA) | Active Comparator | Participants who receive standard PTA treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DCB | Device | Drug Coated Balloon |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Effectiveness Endpoint: Late Lumen Loss (LLL) at 9 Months | Late lumen loss (LLL) - The difference between minimum lumen diameter (MLD) immediately after percutaneous balloon angioplasty PTA and MLD at follow up, measured at 9 months | 9 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Composite Safety Endpoint | A composite of freedom from device- and procedure-related mortality within 30 days, freedom from major target limb amputation and freedom from clinically-driven target lesion revascularization (CD-TLR) within 9 months post-index procedure | 9 Months |
| Major Adverse Event (MAE) Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Sint Blasius | Dendermonde | East-Flanders | 9200 | Belgium | ||
| ZOL Genk |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34602386 | Derived | Liistro F, Weinberg I, Almonacid Popma A, Shishehbor MH, Deckers S, Micari A. Paclitaxel-coated balloons versus percutaneous transluminal angioplasty for infrapopliteal chronic total occlusions: the IN.PACT BTK randomised trial. EuroIntervention. 2022 Apr 1;17(17):e1445-e1454. doi: 10.4244/EIJ-D-21-00444. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Drug Coated Balloon IN.PACT 014 | Participants who receive IN.PACT 014 |
| FG001 | Percutaneous Transluminal Angioplasty (PTA) | Participants who receive standard PTA treatment |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Study sites identified 25 target lesions in the IN.PACT 014 group and 30 in the PTA group. All site-reported lesion characteristics use 25 as the denominator for the IN.PACT 014 group and 30 as the denominator for the PTA group. CoreLab identified 24 target lesions in the IN.PACT 014 group and 29 in the PTA group. Therefore, all CoreLab reported lesion characteristics use 24 as the denominator for the IN.PACT 014 group and 29 as the denominator for the PTA group.
| ID | Title | Description |
|---|---|---|
| BG000 | Drug Coated Balloon IN.PACT 014 | Participants who receive IN.PACT 014 |
| BG001 | Percutaneous Transluminal Angioplasty (PTA) | Participants who receive standard PTA treatment |
| 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 | Primary Effectiveness Endpoint: Late Lumen Loss (LLL) at 9 Months | Late lumen loss (LLL) - The difference between minimum lumen diameter (MLD) immediately after percutaneous balloon angioplasty PTA and MLD at follow up, measured at 9 months | 3 participants were missing data in IN.PACT 014 arm, and 3 participants were missing data in the PTA arm. | Posted | Mean | Standard Deviation | mm | 9 Months |
|
1800 Days (60 Months)
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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 | Drug Coated Balloon IN.PACT 014 | Participants who receive IN.PACT 014 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IMPAIRED HEALING | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Giulia Gatta, Clinical Study Manager | Medtronic | +310629467793 | giulia.gatta@medtronic.com |
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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 | Jun 11, 2020 | Feb 7, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 24, 2022 | Apr 18, 2025 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000089802 | Chronic Limb-Threatening Ischemia |
| D058729 | Peripheral Arterial Disease |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
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| PTA |
| Device |
Percutaneous Transluminal Angioplasty |
|
defined as a composite of all-cause mortality, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) Reported by using the event-free survival Kaplan-Meier estimate through 60 months |
| through 3, 6, 9, 12, 24, 36, 48 and 60 months |
| Functional Flow Assessment | is defined as absence of target lesion occlusion (no flow) assessed by duplex ultrasound. | at 3, 6, 9, 12, 24 and 36 months |
| Death of Any Cause | Death of any cause, reported by using the event-free survival Kaplan-Meier estimate through 60 months | through 3, 6, 9, 12, 24, 36, 48 and 60 months |
| Major Target Limb Amputation Rate | Major Target Limb Amputation rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months | through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months |
| Clinically-driven Target Lesion Revascularization (CD-TLR) Rate | Clinically-driven Target Lesion Revascularization (CD-TLR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months | through 3, 6, 9, 12, 24, 36, 48 and 60 months |
| Mechanically-driven Target Lesion Revascularization (TLR) Rate | Mechanically-driven Target Lesion Revascularization (TLR) rate | through 37 days |
| Target Lesion Revascularization (TLR) Rate | Target Lesion Revascularization (TLR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months | through 3, 6, 9, 12, 24, 36, 48 and 60 months |
| Clinically-driven Target Vessel Revascularization (CD-TVR) Rate | Clinically-driven Target Vessel Revascularization (CD-TVR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months | through 3, 6, 9, 12, 24, 36, 48 and 60 months |
| Target Vessel Revascularization (TVR) Rate | Target Vessel Revascularization (TVR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months | through 3, 6, 9, 12, 24, 36, 48 and 60 months |
| Status of Wound Healing | Status of wound healing for baseline wounds: completely healed - improvement - unchanged - worsened - Amputation - skin graft; percentage of wounds in each category is presented for each treatment arm | at 30 days, 3, 6, 9, 12, 24 and 36 months |
| Rate of Thrombosis at the Target Lesion | Rate of thrombosis at the target lesion, reported by using the event-free survival Kaplan-Meier estimate through 60 months | through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months |
| Device Success | Calculated as the number of IN.PACT 014 Investigational devices with successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP), divided by the total number of IN.PACT 014 Investigational devices assessed in the study | at the time of procedure |
| Clinical Success | Clinical success is defined as residual stenosis of ≤ 30% without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or target vessel revascularization (TVR)). If any lesion has residual stenosis > 30% or any of the complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge, then subject is not counted as having Clinical Success. Clinical success is calculated as the number of index procedures with residual stenosis of ≤ 30% by core lab (use site reported data if core lab data is not available) for all target lesions and without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge as adjudicated by CEC, divided by the number of total index procedures performed. | up to discharge visit [between index procedure and 30-day (+/- 7 days) follow-up visit. The average days until discharge was: 9 days (with a max. of 31days) in the IN.PACT 014 arm, and 6 days (with a max. of 21days) in the PTA arm.] |
| Genk |
| Limburg |
| 3600 |
| Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| Hopital Guillaume et Rene Laennec - Centre Hospitalier Universitaire | Nantes | France |
| University Hospital Patras | Pátrai | Greece |
| IRCCS Multimedica | Sesto San Giovanni | Lombardy | 20099 | Italy |
| Maria Cecilia Hospital | Cotignola | Ravenna | 48033 | Italy |
| Ospedale San Donato | Arezzo | 50200 | Italy |
| University Hospital Zurich | Zurich | Switzerland |
| BG002 | Total | Total of all reporting groups |
| 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 |
|
|
| Obesity, BMI >=30kg/m2 | Denominator is subjects with available data. | Count of Participants | Participants | Participants |
|
|
| Diabetes Mellitus | Count of Participants | Participants | Participants |
|
|
| Diabetes Mellitus Insulin-dependent | Count of Participants | Participants | Participants |
|
|
| Hypertension | Count of Participants | Participants | Participants |
|
|
| Hyperlipideamia | Denominator is subjects with available data. | Count of Participants | Participants | Participants |
|
|
| Current smoker | Denominator is subjects with available data. | Count of Participants | Participants | Participants |
|
|
| End-stage renal disease | Count of Participants | Participants | Participants |
|
|
| Cerebrovascular disease | Denominator is subjects with available data. | Count of Participants | Participants | Participants |
|
|
| Congestive heart failure | Denominator is subjects with available data. | Count of Participants | Participants | Participants |
|
|
| Ischaemic heart disease | Denominator is subjects with available data. | Count of Participants | Participants | Participants |
|
|
| Bilateral PAD | Denominator is subjects with available data. | Count of Participants | Participants | Participants |
|
|
| Previous peripheral revascularisation of target limb | Count of Participants | Participants | Participants |
|
|
| Previous minor target limb amputation | Count of Participants | Participants | Participants |
|
|
| Rutherford category 4 | RUTHERFORD-BECKER SCALE (Clinical Category) 4 = Ischemic rest pain. Increased score is a worse outcome for Critical Limb Ischemia. | Count of Participants | Participants | Participants |
|
|
| Rutherford category 5 | RUTHERFORD-BECKER SCALE (Clinical Category) 5 = Minor tissue loss, focal gangrene with diffuse pedal ischemia. Increased score is a worse outcome for Critical Limb Ischemia. | Count of Participants | Participants | Participants |
|
|
| Rutherford category 6 | RUTHERFORD-BECKER SCALE (Clinical Category) 6 = Major tissue loss-extending transmetatarsally; functional foot no longer salvageable. Increased score is a worse outcome for Critical Limb Ischemia. | Count of Participants | Participants | Participants |
|
|
| Target lesion location - Popliteal P3 segment | Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement. | Count of Units | Lesions | Lesions |
|
|
| Target lesion location - Tibio-peroneal trunk | Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement. | Count of Units | Lesions | Lesions |
|
|
| Target lesion location - Anterior tibial | Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement. | Count of Units | Lesions | Lesions |
|
|
| Target lesion location - posterior tibial | Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement. | Count of Units | Lesions | Lesions |
|
|
| Target lesion location - Peroneal | Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement. | Count of Units | Lesions | Lesions |
|
|
| Inflow in the target vessel (<30% residual stenosis) | Participant-based assessment. Denominator is subjects with available data. | Count of Participants | Participants | Participants |
|
|
| Lesion type - De novo | Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement. Number of Participants DCB = 23; Number of Participants PTA = 27; Total Number of Participants = 50. | Count of Units | Lesions | Lesions |
|
|
| Lesion type - Restenotic (non-stented) | Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement. Number of Participants DCB = 23; Number of Participants PTA = 27; Total Number of Participants = 50. | Count of Units | Lesions | Lesions |
|
|
| Lesion length | Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement. | Mean | Standard Deviation | mm | Lesions |
|
|
| Occluded lesion (site reported data) | Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement. Number of Participants DCB = 23; Number of Participants PTA = 27; Total Number of Participants = 50. | Count of Units | Lesions | Lesions |
|
|
| Total occluded lesion length, mm | Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement. | Mean | Standard Deviation | mm | Lesions |
|
|
| Diameter Stenosis, % | Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement. | Mean | Standard Deviation | % | Lesions |
|
|
| Reference vessel diameter, mm | Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement. | Mean | Standard Deviation | mm | Lesions |
|
|
| Minimum lumen diameter, mm | Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement. | Mean | Standard Deviation | mm | Lesions |
|
|
| Calcification | Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement. | Count of Units | Lesions | Lesions |
|
|
| Calcification - mild/moderate | Calcium is visible along one side of the arterial wall in the area of the target lesion prior to injection of contrast. The calcium present encompasses < 50% of the total target lesion treatment area by visual estimate and/or the calcium is not circumferential (360°) in nature (i.e. on both sides of the vessel lumen extending 2 cm or greater on a single AP view) or classified as exophytic calcification, no impedance of blood flow in the vessel. | Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement. | Count of Units | Lesions | Lesions |
|
|
| Calcification - moderate/severe | Calcium is visible along one or both sides of the arterial wall in the area of the target lesion. The calcium present encompasses ≤ 50% of total target lesion treatment area by visual estimate and/ the calcium is not circumferential (360°) in nature (i.e. on both sides of the vessel lumen extending 2 cm or greater on a single AP view) or classified as exophytic calcification, and does not impede blood flow by more than 50%. | Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement. | Count of Units | Lesions | Lesions |
|
|
| Calcification - severe | Calcium is visible along both sides of the arterial wall, covers 2 cm or greater of the target lesion area, encompasses greater than 50% of the total target lesion treatment area by visual estimate and/or the calcium is circumferential (360°) in nature (i.e. on both sides of the vessel lumen extending 2 cm or greater on a single AP view) or classified as exophytic calcification, significantly impedes blood flow in the vessel. | Lesion based measurement. Number of analyzed units corresponds to number of lesions with available data. Participant analysis not performed, as this is a lesion-based measurement. | Count of Units | Lesions | Lesions |
|
|
| TASC II - A | TransAtlantic Inter-Society Consensus; TASC II classification spans from grading A (mildly complex lesions), to D (severe complex lesions). Increased grades indicate more severe lesions. | Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement. | Count of Units | Lesions | Lesions |
|
|
| TASC II - B | TransAtlantic Inter-Society Consensus; TASC II classification spans from grading A (mildly complex lesions), to D (severe complex lesions). Increased grades indicate more severe lesions. | Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement. | Count of Units | Lesions | Lesions |
|
|
| TASC II - C | TransAtlantic Inter-Society Consensus; TASC II classification spans from grading A (mildly complex lesions), to D (severe complex lesions). Increased grades indicate more severe lesions. | Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement. | Count of Units | Lesions | Lesions |
|
|
| TASC II - D | TransAtlantic Inter-Society Consensus; TASC II classification spans from grading A (mildly complex lesions), to D (severe complex lesions). Increased grades indicate more severe lesions. | Lesion based measurement. CoreLab reported data; Overall N Lesions DCB = 24; Overall N Lesions PTA = 29 Participant analysis not performed, as this is a lesion-based measurement. | Count of Units | Lesions | Lesions |
|
|
|
|
| Secondary | Composite Safety Endpoint | A composite of freedom from device- and procedure-related mortality within 30 days, freedom from major target limb amputation and freedom from clinically-driven target lesion revascularization (CD-TLR) within 9 months post-index procedure | Posted | Count of Participants | Participants | 9 Months |
|
|
|
| Secondary | Major Adverse Event (MAE) Rate | defined as a composite of all-cause mortality, target limb major amputation and clinically-driven target lesion revascularization (CD-TLR) Reported by using the event-free survival Kaplan-Meier estimate through 60 months | number analyzed in one or more rows indicates the number analyzed at each timepoint | Posted | Number | 95% Confidence Interval | probability | through 3, 6, 9, 12, 24, 36, 48 and 60 months |
|
|
|
| Secondary | Functional Flow Assessment | is defined as absence of target lesion occlusion (no flow) assessed by duplex ultrasound. | Participant analysis not performed, as this is a lesion-based measurement. | Posted | Count of Units | Lesions | at 3, 6, 9, 12, 24 and 36 months | Lesions | Lesions |
|
|
|
| Secondary | Death of Any Cause | Death of any cause, reported by using the event-free survival Kaplan-Meier estimate through 60 months | number analyzed in one or more rows indicates the number analyzed at each timepoint | Posted | Number | 95% Confidence Interval | probability | through 3, 6, 9, 12, 24, 36, 48 and 60 months |
|
|
|
| Secondary | Major Target Limb Amputation Rate | Major Target Limb Amputation rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months | number analyzed in one or more rows indicates the number analyzed at each timepoint | Posted | Number | 95% Confidence Interval | probability | through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months |
|
|
|
| Secondary | Clinically-driven Target Lesion Revascularization (CD-TLR) Rate | Clinically-driven Target Lesion Revascularization (CD-TLR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months | number analyzed in one or more rows indicates the number analyzed at each timepoint | Posted | Number | 95% Confidence Interval | probability | through 3, 6, 9, 12, 24, 36, 48 and 60 months |
|
|
|
| Secondary | Mechanically-driven Target Lesion Revascularization (TLR) Rate | Mechanically-driven Target Lesion Revascularization (TLR) rate | Number of subjects undergo MD-TLR within 37 days post-index procedure adjudicated by CEC divided by the number of evaluable subjects at 37 days. | Posted | Count of Participants | Participants | through 37 days |
|
|
|
| Secondary | Target Lesion Revascularization (TLR) Rate | Target Lesion Revascularization (TLR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months | Number analyzed in one or more rows indicates the number analyzed at each timepoint | Posted | Number | 95% Confidence Interval | probability | through 3, 6, 9, 12, 24, 36, 48 and 60 months |
|
|
|
| Secondary | Clinically-driven Target Vessel Revascularization (CD-TVR) Rate | Clinically-driven Target Vessel Revascularization (CD-TVR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months | number analyzed in one or more rows indicates the number analyzed at each timepoint | Posted | Number | 95% Confidence Interval | probability | through 3, 6, 9, 12, 24, 36, 48 and 60 months |
|
|
|
| Secondary | Target Vessel Revascularization (TVR) Rate | Target Vessel Revascularization (TVR) rate, reported by using the event-free survival Kaplan-Meier estimate through 60 months | number analyzed in one or more rows indicates the number analyzed at each timepoint | Posted | Number | 95% Confidence Interval | probability | through 3, 6, 9, 12, 24, 36, 48 and 60 months |
|
|
|
| Secondary | Status of Wound Healing | Status of wound healing for baseline wounds: completely healed - improvement - unchanged - worsened - Amputation - skin graft; percentage of wounds in each category is presented for each treatment arm | This is a wound-based measurement. Numbers are % (counts/number of wounds with data). Each participant could report one or more baseline wounds, or none. Therefore, the overall number of participants analyzed may not correspond to the number of wounds analyzed. Number of participants analyzed at each timepoint indicates the number of participants with at least one Baseline Wound. 21 wounds in the IN.PACT 014 arm, and 25 wounds were analyzed in the PTA arm, based on available data. | Posted | Count of Units | Baseline wounds | at 30 days, 3, 6, 9, 12, 24 and 36 months | Baseline wounds | Baseline wounds |
|
|
|
| Secondary | Rate of Thrombosis at the Target Lesion | Rate of thrombosis at the target lesion, reported by using the event-free survival Kaplan-Meier estimate through 60 months | number analyzed in one or more rows indicates the number analyzed at each timepoint | Posted | Number | 95% Confidence Interval | probability | through 30 days, 3, 6, 9, 12, 24, 36, 48 and 60 months |
|
|
|
| Secondary | Device Success | Calculated as the number of IN.PACT 014 Investigational devices with successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP), divided by the total number of IN.PACT 014 Investigational devices assessed in the study | 68 IN.PACT 014 Investigational devices used | Posted | Count of Units | IN.PACT 014 Investigational devices | at the time of procedure | IN.PACT 014 Investigational devices | IN.PACT 014 Investigational devices |
|
|
|
| Secondary | Clinical Success | Clinical success is defined as residual stenosis of ≤ 30% without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or target vessel revascularization (TVR)). If any lesion has residual stenosis > 30% or any of the complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge, then subject is not counted as having Clinical Success. Clinical success is calculated as the number of index procedures with residual stenosis of ≤ 30% by core lab (use site reported data if core lab data is not available) for all target lesions and without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge as adjudicated by CEC, divided by the number of total index procedures performed. | Posted | Count of Participants | Participants | up to discharge visit [between index procedure and 30-day (+/- 7 days) follow-up visit. The average days until discharge was: 9 days (with a max. of 31days) in the IN.PACT 014 arm, and 6 days (with a max. of 21days) in the PTA arm.] |
|
|
|
| 23 |
| 19 |
| 23 |
| 13 |
| 23 |
| EG001 | Percutaneous Transluminal Angioplasty (PTA) | Participants who receive standard PTA treatment | 9 | 27 | 25 | 27 | 24 | 27 |
| DISSEMINATED INTRAVASCULAR COAGULATION | Blood and lymphatic system disorders | Systematic Assessment |
|
| ACUTE CORONARY SYNDROME | Cardiac disorders | Systematic Assessment |
|
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | Systematic Assessment |
|
| ANGINA UNSTABLE | Cardiac disorders | Systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | Systematic Assessment |
|
| ATRIOVENTRICULAR BLOCK SECOND DEGREE | Cardiac disorders | Systematic Assessment |
|
| CARDIAC ARREST | Cardiac disorders | Systematic Assessment |
|
| CARDIAC FAILURE | Cardiac disorders | Systematic Assessment |
|
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | Systematic Assessment |
|
| CARDIO-RESPIRATORY ARREST | Cardiac disorders | Systematic Assessment |
|
| CORONARY ARTERY DISEASE | Cardiac disorders | Systematic Assessment |
|
| CORONARY ARTERY OCCLUSION | Cardiac disorders | Systematic Assessment |
|
| MICROVASCULAR CORONARY ARTERY DISEASE | Cardiac disorders | Systematic Assessment |
|
| MYOCARDIAL INFARCTION | Cardiac disorders | Systematic Assessment |
|
| MYOCARDIAL ISCHAEMIA | Cardiac disorders | Systematic Assessment |
|
| ABDOMINAL WALL HAEMATOMA | Gastrointestinal disorders | Systematic Assessment |
|
| FOOD POISONING | Gastrointestinal disorders | Systematic Assessment |
|
| INGUINAL HERNIA | Gastrointestinal disorders | Systematic Assessment |
|
| PANCREATITIS ACUTE | Gastrointestinal disorders | Systematic Assessment |
|
| DEATH | General disorders | Systematic Assessment |
|
| IMPAIRED HEALING | General disorders | Systematic Assessment |
|
| VASCULAR STENT OCCLUSION | General disorders | Systematic Assessment |
|
| VASCULAR STENT THROMBOSIS | General disorders | Systematic Assessment |
|
| BILE DUCT STONE | Hepatobiliary disorders | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
| COVID-19 PNEUMONIA | Infections and infestations | Systematic Assessment |
|
| ENDOCARDITIS | Infections and infestations | Systematic Assessment |
|
| ENDOCARDITIS PSEUDOMONAL | Infections and infestations | Systematic Assessment |
|
| GANGRENE | Infections and infestations | Systematic Assessment |
|
| INFECTED SKIN ULCER | Infections and infestations | Systematic Assessment |
|
| KLEBSIELLA INFECTION | Infections and infestations | Systematic Assessment |
|
| OSTEOMYELITIS | Infections and infestations | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | Systematic Assessment |
|
| POSTOPERATIVE WOUND INFECTION | Infections and infestations | Systematic Assessment |
|
| SEPSIS | Infections and infestations | Systematic Assessment |
|
| SEPTIC SHOCK | Infections and infestations | Systematic Assessment |
|
| STAPHYLOCOCCAL SEPSIS | Infections and infestations | Systematic Assessment |
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| UROSEPSIS | Infections and infestations | Systematic Assessment |
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| WOUND INFECTION | Infections and infestations | Systematic Assessment |
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| CRANIOCEREBRAL INJURY | Injury, poisoning and procedural complications | Systematic Assessment |
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| LIMB INJURY | Injury, poisoning and procedural complications | Systematic Assessment |
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| PELVIC FRACTURE | Injury, poisoning and procedural complications | Systematic Assessment |
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| PERIPHERAL ARTERIAL REOCCLUSION | Injury, poisoning and procedural complications | Systematic Assessment |
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| PERIPHERAL ARTERY RESTENOSIS | Injury, poisoning and procedural complications | Systematic Assessment |
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| SUBDURAL HAEMATOMA | Injury, poisoning and procedural complications | Systematic Assessment |
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| WOUND DEHISCENCE | Injury, poisoning and procedural complications | Systematic Assessment |
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| BLOOD CREATININE INCREASED | Investigations | Systematic Assessment |
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| LUMBAR SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| METASTATIC GASTRIC CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| CAROTID ARTERY STENOSIS | Nervous system disorders | Systematic Assessment |
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| SPONDYLITIC MYELOPATHY | Nervous system disorders | Systematic Assessment |
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| SUBARACHNOID HAEMORRHAGE | Nervous system disorders | Systematic Assessment |
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| SYNCOPE | Nervous system disorders | Systematic Assessment |
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| DEVICE DEFECTIVE | Product Issues | Systematic Assessment |
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| COMPLETED SUICIDE | Psychiatric disorders | Systematic Assessment |
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| CONFUSIONAL STATE | Psychiatric disorders | Systematic Assessment |
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| ACUTE KIDNEY INJURY | Renal and urinary disorders | Systematic Assessment |
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| HAEMATURIA | Renal and urinary disorders | Systematic Assessment |
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| PROSTATITIS | Reproductive system and breast disorders | Systematic Assessment |
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| ACUTE PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| ACUTE RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| PULMONARY OEDEMA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| RESPIRATORY FAILURE | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| DIABETIC WOUND | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| HYPERKERATOSIS | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| ISCHAEMIC SKIN ULCER | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| SKIN NECROSIS | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| SKIN ULCER | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| CARDIAC PACEMAKER REPLACEMENT | Surgical and medical procedures | Systematic Assessment |
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| PERIPHERAL ARTERY ANGIOPLASTY | Surgical and medical procedures | Systematic Assessment |
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| AORTIC ANEURYSM RUPTURE | Vascular disorders | Systematic Assessment |
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| EXTREMITY NECROSIS | Vascular disorders | Systematic Assessment |
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| ISCHAEMIA | Vascular disorders | Systematic Assessment |
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| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | Vascular disorders | Systematic Assessment |
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| PERIPHERAL ARTERY OCCLUSION | Vascular disorders | Systematic Assessment |
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| PERIPHERAL ARTERY STENOSIS | Vascular disorders | Systematic Assessment |
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| PERIPHERAL ARTERY THROMBOSIS | Vascular disorders | Systematic Assessment |
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| PERIPHERAL ISCHAEMIA | Vascular disorders | Systematic Assessment |
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| LIMB INJURY | Injury, poisoning and procedural complications | Systematic Assessment |
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| PERIPHERAL ARTERIAL REOCCLUSION | Injury, poisoning and procedural complications | Systematic Assessment |
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| PERIPHERAL ARTERY RESTENOSIS | Injury, poisoning and procedural complications | Systematic Assessment |
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| SKIN ULCER | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| PERIPHERAL ARTERY ANEURYSM | Vascular disorders | Systematic Assessment |
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| PERIPHERAL ARTERY DISSECTION | Vascular disorders | Systematic Assessment |
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| PERIPHERAL ARTERY OCCLUSION | Vascular disorders | Systematic Assessment |
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| PERIPHERAL ARTERY STENOSIS | Vascular disorders | Systematic Assessment |
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Not provided
| D002318 |
| Cardiovascular Diseases |
| D016491 | Peripheral Vascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007511 | Ischemia |
| through 9 months |
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| through 12 months |
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| through 24 months |
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| through 36 months |
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| through 48 months |
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| through 60 months |
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| At 6 Months |
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| At 12 Months |
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| At 24 Months |
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| At 36 Months |
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| Through 9 months |
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| Through 12 months |
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| Through 24 months |
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| Through 36 months |
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| Through 48 months |
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| Through 60 months |
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| Through 6 months |
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| Through 9 months |
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| Through 12 months |
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| Through 24 months |
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| Through 36 months |
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| Through 48 months |
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| Through 60 months |
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| Through 9 months |
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| Through 12 months |
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| Through 24 months |
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| Through 36 months |
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| Through 48 months |
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| Through 60 months |
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| Through 9 months |
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| Through 12 months |
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| Through 24 months |
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| Through 36 months |
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| Through 48 months |
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| Through 60 months |
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| Through 9 months |
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| Through 12 months |
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| Through 24 months |
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| Through 36 months |
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| Through 48 months |
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| Through 60 months |
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| Through 9 months |
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| Through 12 months |
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| Through 24 months |
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| Through 36 months |
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| Through 48 months |
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| Through 60 months |
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| Within 3 Months |
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| Within 6 Months |
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| Within 9 Months |
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| Within 12 Months |
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| Within 24 Months |
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| Within 36 Months |
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| Through 6 months |
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| Through 9 months |
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| Through 12 months |
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| Through 24 months |
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| Through 36 months |
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| Through 48 months |
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| Through 60 months |
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| Unchanged |
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| Worsened |
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| Amputation |
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| Skin graft |
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| Unchanged |
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| Worsened |
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| Amputation |
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| Skin graft |
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| Unchanged |
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| Worsened |
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| Amputation |
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| Skin graft |
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| Unchanged |
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| Worsened |
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| Amputation |
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| Skin graft |
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| Unchanged |
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| Worsened |
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| Amputation |
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| Skin graft |
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| Unchanged |
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| Worsened |
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| Amputation |
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| Skin graft |
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