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Sections: Correlations,
Clinical Trials, and HPO
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| drug2861 | Percutaneous Transluminal Angioplasty (PTA) Device Wiki | 1.00 |
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Navigate: Correlations HPO
There is one clinical trial.
Pre-market clinical evaluation of the everolimus eluting ESPRIT™ BTK System for the planned treatment of narrowed infrapopliteal lesions.
Description: It includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR).
Measure: Composite of Limb Salvage and Primary Patency at 6 Months Time: At 6 monthsDescription: MALE includes above ankle amputation in index limb, major re-intervention at 6 months and POD includes perioperative (30 day) mortality.
Measure: Freedom from MALE+POD (Major Adverse Limb Event + Peri-Operative Death) Time: At 30 days (for POD) and 6 months (for MALE)Description: Successful target lesion treatment is defined as final diameter stenosis < 30% with final number of run-off vessels equivalent to or greater than number of run-off vessels at pre-procedure, with no residual dissection NHLBI grade ≥ type C, and no transient or sustained angiographic complications (e.g. distal embolization, perforation, thrombosis). Achieved using balloons plus ESPRIT BTK in the treatment arm and balloons in the control arm. This is defined on a per lesion basis.
Measure: Number of Participants with Acute Procedure Success Time: Immediately after the procedureDescription: Device success is defined on a per device basis, as the achievement of successful delivery and deployment of the study device(s) at the intended target lesion and successful withdrawal of the delivery catheter.
Measure: Number of Participants with Device Success Time: During the procedureDescription: Technical success is defined on a per lesion basis as the attainment of a final residual stenosis of < 30% at the intended target lesion(s) following use of the study device(s). Standard pre-dilatation catheters and post-dilatation catheters (if applicable) may be used. Bailout at lesion level does not impact technical success if the above criteria are met.
Measure: Number of Participants with Technical Success Time: During the procedureDescription: Clinical success is defined on a per patient basis, as the attainment of a final residual stenosis of < 30% using the study device(s) and/or any adjunctive device at all intended target lesion(s) without complications within 2 days after the index procedure or at hospital discharge, whichever is sooner.
Measure: Number of Participants with Clinical Success Time: Within 2 days after the index procedure or at hospital dischargeDescription: Acute gain is defined as the difference between post- and preprocedural minimal lumen diameter (MLD).
Measure: Number of Participants with Angiographic acute gain (in-segment) Time: Immediately after the procedureDescription: Acute gain is defined as the difference between post- and preprocedural minimal lumen diameter (MLD). Angiographic acute gain (in-device) will be assessed for ESPRIT arm only
Measure: Number of Participants with Angiographic acute gain (in-device) Time: Immediately after the procedureDescription: Composite of Limb Salvage and Primary Patency includes freedom from: above ankle amputation in index limb, 100% total occlusion of target vessel and clinically-driven target lesion revascularization (CD-TLR).
Measure: Composite of Limb Salvage and Primary Patency Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 yearsDescription: MALE includes above ankle amputation in index limb, major re-interventions at 1 month, 3 months, 6 months, 1 year and annually through 5 years, and POD includes perioperative (30 day) mortality.
Measure: Freedom From MALE+POD (Major Adverse Limb Event + Peri-Operative Death) Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 yearsDescription: Freedom from re-narrowing of the artery following the alleviation of a previous narrowing. It is defined as the presence of a hemodynamically significant restenosis (≥ 50%), as determined by angiography.
Measure: Freedom From Restenosis Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 yearsDescription: All-cause Death composed of cardiac death, vascular death and non-cardiovascular death
Measure: Number of All-cause Death Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 yearsDescription: Arterial thrombosis is defined as a total occlusion documented by duplex ultrasound and/or angiography at the site of the treated lesion with or without symptoms. Acute thrombosis: 0 - 24 hours post study procedure Subacute thrombosis: > 24 hours - 30 days post study procedure Late thrombosis: 31 days - 1 year post-procedure Very late thrombosis: > 1 year post-procedure Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the arterial sheath has been removed and the subject has left the interventional lab.
Measure: Number of Participants with Arterial Thrombosis Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 yearsDescription: Major Limb Re-interventions includes the creation of a new bypass graft, bypass graft revision, the use of thrombectomy or thrombolysis, or revascularization
Measure: Number of Participants with Major Re-intervention on index limb Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 yearsDescription: Primary assisted patency is defined as patency of the target lesion following endovascular reintervention at the target vessel site in case of symptomatic restenosis
Measure: Primary Assisted Patency Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 yearsDescription: Secondary patency is defined as patency of the target lesion after treatment of a (re)occlusion of the index lesion
Measure: Secondary Patency Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 yearsDescription: CD-TLR is the repeat intervention on the target lesion due to recurrent symptoms AND stenosis > 70% by angiography
Measure: Number of Participants with Clinically-driven Target Lesion Revascularization (CD-TLR) Time: At 1 month, 3 months, 6 months, 1 year and annually through 5 yearsDescription: Wound assessment will be performed to determine whether the wound is improving (i.e. healing), not changing, or worsening.
Measure: Target Wound Assessment for Healing Time: At 14 days, 30 days, 42 days and 90 daysDescription: Wound Assessment for Infection will be performed to determine the clinical indication of the presence or absence of infection.
Measure: Target Wound Assessment for Infection Time: At 14 days, 30 days, 42 days and 90 daysDescription: The Rutherford Becker scale is a classification system for claudication and limb ischemia. Categories and Clinical Description: Category 0 = Asymptomatic, no hemodynamically significant occlusive disease Grade I (Category 1 = Mild claudication, Category 2 = Moderate claudication, Category 3 = Severe claudication) Grade II (Category 4 = Ischemic rest pain) Grade III (Category 5 = Minor tissue loss, non-healing ulcer, or focal gangrene with diffuse pedal ischemia, Category 6 = Major tissue loss, extending above transmetatarsal level, functional foot no longer salvageable).
Measure: Measurement of subject's Rutherford Becker Clinical Category, and change from baseline for the treated limb Time: At baseline,1 month, 3 months, 6 months, 1 year and annually through 5 yearsAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports