An interventional study of Duplex Ultrasound (DUS) and IVUS with Intraarterial pressure measurement (IAP) if needed in Peripheral Arterial Disease, sponsored by Biotronik AG. Status unknown at 15 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-29.
Sponsored by Biotronik AG · Not applicable, Interventional, and Diagnostic
Both drug-coated balloon and stents have been used for a number of years to treat subjects with Peripheral Artery Disease (PAD) and are recognized as very good treatment methods. However, due to a higher risk of blood clot formation, requiring a longer anticoagulant treatment, and the challenge of treating re growth of tissue extending through the metal mesh of the stent, the physicians try to reserve stent placement to situation where it's really needed, in case of flow-limiting vessel dissection or acute re-narrowing.
The purpose of this study is to evaluate the utility of several procedural diagnostic techniques in helping the physicians to better decide whether a stent is needed or not.
The study will also estimate the safety and efficacy of Passeo-18 Lux drug-coated balloon associated to Pulsar 18 bare metal stent when and where needed to treat PAD
The REACT treatment concept aims at minimizing the metal burden, combining Passeo-18 Lux Drug-Coated Balloon (DCB) with Pulsar-18 thin struts bare metal stent, as low as reasonably achievable (ALARA), while benefiting from the antirestenotic properties of Paclitaxel. However, in order to optimally apply this selective stenting approach, it is needed to clearly identify when a stent is indicated. Angiographic images, even with additional projections, are sometimes insufficient to clearly determine if a dissection is flow-limiting and the subsequent stent requirement. There is currently no definition nor validated method to define flow-limiting dissection in the peripheral arteries. Even though it has been widely used, the classification developed by the National Heart, Lung, and Blood Institute to grade coronary artery dissection as A to F19, based on angiographic appearance cannot be extrapolated to peripheral arteries.
Therefore, the purpose of the study is to evaluate the incremental value of several adjunctive procedural assessments to standard angiography to identify flow-limiting dissection and residual stenosis, and better inform the operator on the stent requirement. In addition, the study will evaluate the safety and efficacy of the REACT algorithm.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's planned enrollment of 150 is above the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Biotronik AG is the lead sponsor of 39 studies on the registry; 3 are open to participants now.
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Angiographic criteria:
Exclusion Criteria:
Standard angiography and DUS are performed on the same patients (paired data)
Diagnostic Test: Duplex Ultrasound (DUS)
Standard angiography and Intra-Vascular Ultrasound (IVUS) with Intraarterial pressure measurement (IAP) are performed on the same patients (paired data)
Diagnostic Test: IVUS with Intraarterial pressure measurement (IAP) if needed
Occurrence of a flow-limiting dissection or residual stenosis will be assessed by standard angiography and Duplex Ultrasound
Also known as: Procedural diagnostic with Duplex Ultrasound (DUS)
Occurrence of a flow-limiting dissection or residual stenosis will be assessed by standard angiography and Intra-vascular ultrasound associated to Intraarterial pressure measurement if needed
Also known as: Procedural diagnostic with IVUS and Intraarterial pressure measurement (IAP)
diagnostic accuracy of duplex ultrasound
specificity and sensitivity of duplex ultrasound combined to angiography vs angiography alone
Time frame: during index procedure
diagnostic accuracy of intraarterial pressure measurement
specificity and sensitivity of intraarterial pressure measurement combined to angiography vs angiography alone
Time frame: during index procedure
diagnostic accuracy of intraarterial pressure measurement with IVUS
specificity and sensitivity of intraarterial pressure measurement with IVUS combined to angiography vs angiography alone
Time frame: during index procedure
Target lesion stenting rate
Time frame: during index procedure
Number of stents used per target lesion
Time frame: during index procedure
Average stent length per target lesion
Time frame: during index procedure
Average target lesion length stented (full, spot)
Time frame: during index procedure
DCB technical success
Delivery and successful use of Passeo-18 Lux DCB to the target lesion to achieve a residual stenosis no greater than 30% in the absence of flow-limiting dissection
Time frame: during index procedure
Stent technical success
delivery and successful use of Pulsar-18 to the target lesion to achieve a residual stenosis no greater than 30%
Time frame: during index procedure
Procedural success
technical success and no MAEs before discharge
Time frame: during index procedure
Primary Patency
Primary patency is defined as DUS peak systolic velocity ratio (PSVR) ≤2.5 at the target lesion, in the absence of clinically driven Target Lesion Revascularization (cd TLR).
Time frame: 1, 6 and 12 months post index procedure
Major Adverse Event (MAE)
Major adverse event (MAE) is defined as device or procedure related death within 30 days post index procedure, major target limb amputation or cd TLR post index procedure
Time frame: 1, 6 and 12 months post index procedure
Major Adverse Cardiac Event (MACE)
Major adverse Cardiac event (MACE) is defined as death all causes, myocardial infarction, stroke, death or major amputation
Time frame: 1, 6 and 12 months post index procedure
Major Adverse Limb Event (MALE)
Major adverse limb event (MALE) is defined as severe limb ischemia leading to an intervention or major vascular amputation
Time frame: 1, 6 and 12 months post index procedure
Clinically driven Target Lesion Revascularization
Clinical Event Committee adjudicated TLR =Any post index procedure surgical or percutaneous intervention to the target lesion plus 5 mm proximal and distal to the stented lesion edge when a stent is used
Time frame: 1, 6, 12, 24 and 36 months post index procedure
Major target limb amputation rate
Time frame: 1, 6, 12, 24 and 36 months post index procedure
all cause of death rate
Time frame: 1, 6, 12, 24 and 36 months post index procedure
Hemodynamic improvement
change in Ankel Brachial Index at 1, 6 and 12 months post index procedure compared to baseline
Time frame: 1, 6 and 12 months post index procedure
Rate of primary sustained clinical improvement
Improvement in Rutherford Classification of at least one category for claudicants and by wound-healing and resting pain resolution for critical limb ischemia as compared to pre-procedure without the need for repeat TLR
Time frame: 1, 6 and 12 months post index procedure
Rate of secondary sustained clinical improvement
Improvement in Rutherford Classification of at least one category for claudicants and by wound-healing and resting pain resolution for critical limb ischemia as compared to pre-procedure including the need for repeat TLR
Time frame: 1, 6 and 12 months post index procedure
Health Related Quality of Life
The Euroquol Group 5 dimension quality of life questionnaire (EQ-5D) is a descriptive system comprising 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The results in a 1-digit number expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes patient's health state. The EQ Visual Analogue Scale records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement
Time frame: baseline, 1, 6 and 12 months post index procedure
Walk Impairment
The Walk Impairment Questionnaire (WIQ) measure measures self-reported walking distance, walking speed, and stair-climbing ability
Time frame: baseline, 1, 6 and 12 months post index procedure
Resource utilisation
Costs will be evaluated using specific information on resource use
Time frame: during index procedure, 12 month
Plan to share: No
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This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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Biotronik AG