IN.PACT Amphirion paclitaxel eluting balloon versus standard percutaneous transluminal angioplasty for infrapopliteal revascularization of critical limb ischemia: rationale and protocol ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2014-02-19

AUTHORS

Thomas Zeller, Iris Baumgartner, Dierk Scheinert, Marianne Brodmann, Marc Bosiers, Antonio Micari, Patrick Peeters, Frank Vermassen, Mario Landini

ABSTRACT

BackgroundThe effectiveness and durability of endovascular revascularization therapies for chronic critical limb ischemia (CLI) are challenged by the extensive burden of infrapopliteal arterial disease and lesion-related characteristics (e.g., severe calcification, chronic total occlusions), which frequently result in poor clinical outcomes. While infrapopliteal vessel patency directly affects pain relief and wound healing, sustained patency and extravascular care both contribute to the ultimate “patient-centric” outcomes of functional limb preservation, mobility and quality of life (QoL).Methods/DesignIN.PACT DEEP is a 2:1 randomized controlled trial designed to assess the efficacy and safety of infrapopliteal arterial revascularization between the IN.PACT Amphirion™ paclitaxel drug-eluting balloon (IA-DEB) and standard balloon angioplasty (PTA) in patients with Rutherford Class 4-5-6 CLI.DiscussionThis multicenter trial has enrolled 358 patients at 13 European centers with independent angiographic core lab adjudication of the primary efficacy endpoint of target lesion late luminal loss (LLL) and clinically driven target lesion revascularization (TLR) in major amputation-free surviving patients through 12-months. An independent wound core lab will evaluate all ischemic wounds to assess the extent of healing and time to healing at 1, 6, and 12 months. A QoL questionnaire including a pain scale will assess changes from baseline scores through 12 months. A Clinical Events Committee and Data Safety Monitoring Board will adjudicate the composite primary safety endpoints of all-cause death, major amputation, and clinically driven TLR at 6 months and other trial endpoints and supervise patient safety throughout the study. All patients will be followed for 5 years. A literature review is presented of the current status of endovascular treatment of CLI with drug-eluting balloon and standard PTA. The rationale and design of the IN.PACT DEEP Trial are discussed. IN.PACT DEEP is a milestone, prospective, randomized, robust, independent core lab-adjudicated CLI trial that will evaluate the role of a new infrapopliteal revascularization technology, the IA-DEB, compared to PTA. It will assess the overall impact on infrapopliteal artery patency, limb salvage, wound healing, pain control, QoL, and patient mobility. The 1-year results of the adjudicated co-primary and secondary endpoints will be available in 2014.Trial registrationNCT00941733 More... »

PAGES

63

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/1745-6215-15-63

DOI

http://dx.doi.org/10.1186/1745-6215-15-63

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1006112664

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/24552184


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33 schema:description BackgroundThe effectiveness and durability of endovascular revascularization therapies for chronic critical limb ischemia (CLI) are challenged by the extensive burden of infrapopliteal arterial disease and lesion-related characteristics (e.g., severe calcification, chronic total occlusions), which frequently result in poor clinical outcomes. While infrapopliteal vessel patency directly affects pain relief and wound healing, sustained patency and extravascular care both contribute to the ultimate “patient-centric” outcomes of functional limb preservation, mobility and quality of life (QoL).Methods/DesignIN.PACT DEEP is a 2:1 randomized controlled trial designed to assess the efficacy and safety of infrapopliteal arterial revascularization between the IN.PACT Amphirion™ paclitaxel drug-eluting balloon (IA-DEB) and standard balloon angioplasty (PTA) in patients with Rutherford Class 4-5-6 CLI.DiscussionThis multicenter trial has enrolled 358 patients at 13 European centers with independent angiographic core lab adjudication of the primary efficacy endpoint of target lesion late luminal loss (LLL) and clinically driven target lesion revascularization (TLR) in major amputation-free surviving patients through 12-months. An independent wound core lab will evaluate all ischemic wounds to assess the extent of healing and time to healing at 1, 6, and 12 months. A QoL questionnaire including a pain scale will assess changes from baseline scores through 12 months. A Clinical Events Committee and Data Safety Monitoring Board will adjudicate the composite primary safety endpoints of all-cause death, major amputation, and clinically driven TLR at 6 months and other trial endpoints and supervise patient safety throughout the study. All patients will be followed for 5 years. A literature review is presented of the current status of endovascular treatment of CLI with drug-eluting balloon and standard PTA. The rationale and design of the IN.PACT DEEP Trial are discussed. IN.PACT DEEP is a milestone, prospective, randomized, robust, independent core lab-adjudicated CLI trial that will evaluate the role of a new infrapopliteal revascularization technology, the IA-DEB, compared to PTA. It will assess the overall impact on infrapopliteal artery patency, limb salvage, wound healing, pain control, QoL, and patient mobility. The 1-year results of the adjudicated co-primary and secondary endpoints will be available in 2014.Trial registrationNCT00941733
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41 Data Safety Monitoring Board
42 Deep
43 European Centre
44 In
45 PACT DEEP
46 PTA
47 QOL questionnaire
48 QoL
49 Rutherford class 4
50 adjudication
51 amputation
52 angioplasty
53 arterial disease
54 arterial revascularization
55 artery patency
56 balloon
57 balloon angioplasty
58 baseline scores
59 board
60 burden
61 care
62 cause death
63 center
64 changes
65 characteristics
66 chronic critical limb ischemia
67 class 4
68 clinical events committee
69 clinical outcomes
70 composite primary safety endpoint
71 control
72 core lab
73 critical limb ischemia
74 current status
75 death
76 design
77 disease
78 drug-eluting balloons
79 durability
80 effectiveness
81 efficacy
82 efficacy endpoint
83 endovascular revascularization therapy
84 endovascular treatment
85 endpoint
86 events committee
87 extensive burden
88 extent
89 extent of healing
90 functional limb preservation
91 healing
92 impact
93 infrapopliteal arterial disease
94 infrapopliteal arterial revascularization
95 infrapopliteal revascularization
96 ischemia
97 ischemic wounds
98 lab
99 late luminal loss
100 lesion revascularization
101 lesion-related characteristics
102 life
103 limb ischemia
104 limb preservation
105 limb salvage
106 literature review
107 loss
108 luminal loss
109 major amputation
110 milestones
111 mobility
112 monitoring board
113 months
114 multicenter trial
115 outcomes
116 overall impact
117 paclitaxel
118 paclitaxel drug-eluting balloon
119 pain control
120 pain relief
121 pain scale
122 patency
123 patient mobility
124 patient safety
125 patients
126 percutaneous transluminal angioplasty
127 poor clinical outcome
128 preservation
129 primary efficacy endpoint
130 primary safety endpoint
131 protocol
132 quality
133 quality of life
134 questionnaire
135 rationale
136 relief
137 results
138 revascularization
139 revascularization technologies
140 revascularization therapy
141 review
142 role
143 safety
144 safety endpoint
145 safety monitoring board
146 salvage
147 scale
148 scores
149 secondary endpoints
150 standard PTA
151 standard balloon angioplasty
152 standard percutaneous transluminal angioplasty
153 status
154 study
155 surviving patients
156 target lesion revascularization
157 technology
158 therapy
159 time
160 transluminal angioplasty
161 treatment
162 trial endpoints
163 trials
164 vessel patency
165 wound healing
166 wounds
167 years
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