PREVENT: Promus BTK (PREVENT)
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|ClinicalTrials.gov Identifier: NCT01500070|
Recruitment Status : Completed
First Posted : December 26, 2011
Last Update Posted : August 11, 2016
This is a single-arm, prospective, multi-center monitored trial recruiting patients with critical limb ischemia and with one or more lesions in the arteries below the knee. The immediate and long-term (up to 12 months) outcome of the PROMUS ELEMENT Everolimus-Eluting Stent System (Boston Scientific) and the PROMUS ELEMENT PLUS Everolimus-Eluting Stent System (Boston Scientific) will be evaluated.
In 2 Belgian centers, 3 German centers and 1 New Zealand center a total of 70 patients will be recruited. Primary endpoint is primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on angiography.
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Device: Everolimus-Eluting Stent (PROMUS ELEMENT)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PREVENT: a Prospective, Multi-center, Monitored Trial Investigating the Implant of the Promus Everolimus-Eluting Stent System in Critically Ischemic Lesions BTK|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
Experimental: Drug-eluting stent
Patients implanted with the PROMUS ELEMENT Everolimus-Eluting Stent System (Boston Scientific) or the PROMUS ELEMENT PLUS Everolimus-Eluting Stent System (Boston Scientific).
Device: Everolimus-Eluting Stent (PROMUS ELEMENT)
PROMUS ELEMENT Everolimus-Eluting Stent System (Boston Scientific) or PROMUS ELEMENT PLUS Everolimus-Eluting Stent System (Boston Scientific).
- Primary patency [ Time Frame: 12 months ]Absence of restenosis (50% stenosis) or occlusion within the originally treated lesion based on angiography.
- Technical success [ Time Frame: 1 day post-procedure ]The ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%.
- Hemodynamic primary patency rate [ Time Frame: 1, 6 and 12 month follow-up ]Patients that present without a hemodynamically significant stenosis at the target area on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent at the given follow‐up.
- Limb-salvage [ Time Frame: 1, 6 and 12 month follow-up ]Absence of major amputation, defined as amputation at or above the ankle, as opposed to minor amputation, being an amputation at or below metatarsal level, preserving functionality of the foot).
- Primary assisted patency rate [ Time Frame: 1, 6 and 12 month follow-up ]Defined as flow through the treated lesion maintained by repeat percutaneous intervention completed prior to complete vessel closure.
- Secondary patency rate [ Time Frame: 1, 6 and 12 month follow-up ]Defined as flow through the treated lesion maintained by repeat percutaneous intervention after occlusion of the target lesion.
- Target lesion revascularization (TLR) [ Time Frame: 1 day, 1 month, 6 month and 12 month follow-up ]Defined as a repeat intervention to maintain or re‐establish patency within the region of the treated arterial vessel plus 5 mm proximal and distal to the treated lesion edge.
- Clinical success at follow-up [ Time Frame: 1 day, 1 month, 6 month and 12 month follow-up ]Defined as an improvement of Rutherford classification at 1 day and 1, 6, 12‐month follow‐up of one class or more as compared to the pre‐procedure Rutherford classification.
- Improvement of ankle-brachial index (ABI) [ Time Frame: 1 day, 1 month, 6 month and 12 month follow-up ]Defined as an increase of the ABI at 1 day and 1, 6, 12‐month follow‐up compared to baseline in subjects with compressible arteries and baseline ABI <0.9.
- Serious Adverse Events (SAE) [ Time Frame: 1 day, 1 month, 6 month and 12 month follow-up ]Defined as any clinical event that is fatal, life‐threatening, or judged to be severe by the investigator; resulted in persistent or significant disability; necessitated surgical or percutaneous intervention; or required prolonged hospitalization.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01500070
|Bonheiden, Antwerpen, Belgium, 2820|
|Aalst, Oost-Vlaanderen, Belgium, 9300|
|Dendermonde, Oost-Vlaanderen, Belgium, 9200|
|RZ Heilig Hart Tienen|
|Tienen, Belgium, 3300|
|Leipzig, Freistaat Sachsen, Germany, 04289|
|Bad-Krözingen, Land Baden-Württemberg, Germany, 79189|
|St. Fransiskus Hospital|
|Münster, Nordrhein-Westfalen, Germany, 48145|
|Auckland City Hospital|
|Auckland City, Auckland, New Zealand, 1023|
|Principal Investigator:||Marc Bosiers, MD||AZ Sint Blasius, Dendermonde, Belgium|