NanoCross BTK, a Prospective, Non-randomized, Multicenter, Controlled Trial Evaluating the Performance of the NanoCrossTM .014 Balloon Catheter in Infrapopliteal Lesions
|ClinicalTrials.gov Identifier: NCT01783600|
Recruitment Status : Completed
First Posted : February 5, 2013
Last Update Posted : August 11, 2016
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Arterial Disease||Device: NanoCross .014 balloon catheter||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||NanoCross BTK, a Prospective, Non-randomized, Multicenter, Controlled Trial Evaluating the Performance of the NanoCrossTM .014 Balloon Catheter in Infrapopliteal Lesions|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
NanoCross .014 balloon catheter
NanoCross .014 balloon catheter
Device: NanoCross .014 balloon catheter
- primary Patency [ Time Frame: 12 Months ]Primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on duplex ultrasound (systolic velocity ratio no greater than 2.4) and without prior TLR are defined as being primary patent at the 12-month follow-up
- Technical success [ Time Frame: Day 0 (=procedure date) ]Technical success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%.
- Hemodynamic primary patency [ Time Frame: 1 and 6 months follow-up ]Hemodynamic primary patency rate at 1 and 6-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 rate [ Time Frame: 1, 6 and 12 months follow-up ]Limb-salvage rate at all follow-up visits, defined as absence of major amputation. Major amputation is 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, 12-month follow-up ]Primary assisted patency rate at 1, 6, 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, 12-month follow-up ]Secondary patency rate at 1, 6, 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 [ Time Frame: 1 day, 1 month, 6 month and 12 month follow-up ]Target lesion revascularization (TLR) is 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 and 1, 6, 12-month follow-up ]Clinical success at follow-up is 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.
- Number of patients with Serious Adverse Events (SAE) as a measure of safety [ Time Frame: 1 day, 1 month, 6 month and 12 month follow-up ]Serious adverse events as 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01783600
|Alast, Belgium, 9300|
|Bonheiden, Belgium, 2820|
|Dendermonde, Belgium, 9200|
|RZ Heilig Hart Tienen|
|Tienen, Belgium, 3300|