SNPMiner Trials: Clinical Trial Report
Report for Clinical Trial NCT02956993
Developed by Shray Alag, 2019.
SNP Clinical Trial Gene
The research study is designed to assess the technical feasibility and safety of a
perivascular injection of vonapanitase delivered via micro-infusion catheter to the distal
popliteal, tibial or peroneal arteries immediately following successful angioplasty.
Name: vonapanitase
Type: Drug
Vonapanitase
Name: Placebo
Type: Drug
Placebo
Primary Outcomes
Description: Safety assessments include physical exams and routine serum chemistry and hematology tests
Measure: Incidence of adverse events
Time: Up to 6 months following study drug administration
Description: Technical success of study drug administration will be assessed by the extent of circumferential and longitudinal coverage of the artery using a protocol-defined assessment scale
Measure: Technical success of perivascular injection
Time: Intraprocedural
Other Outcomes
Measure: Minimum lumen diameter [MLD]
Time: Intraprocedural and 6 months following study drug administration
Measure: Minimum lumen area [MLA]
Time: Intraprocedural and 6 months following study drug administration
Measure: Incidence of arterial occlusion
Time: 14 days and 6 months following study drug administration
Measure: Rutherford category
Time: 14 and 28 days, and 6 months following study drug administration
Measure: Ankle-brachial index [ABI]
Time: 14 days and 6 months following study drug administration
Measure: Vascular Quality of Life Questionnaire-6 [VascuQol-6
Time: 14 days and 6 months following study drug administration
Purpose: Treatment
Allocation: Randomized
Parallel Assignment
There is one SNP
SNPs
1 G20210A
6. Known hypercoagulable state (e.g., protein C deficiency, factor V Leiden, prothrombin
G20210A mutation). --- G20210A ---
HPO Nodes
HPO:Peripheral arterial stenosis
Genes 28
MPL TGFB2 TGFB3 JAK2 TGFBR1 LDLRAP1 TGFBR2 MFAP5 APOB MYH11 ELN FBN1 PRKG1 THPO APOE MYLK LMNA LDLR LOX ABCC6 MAT2A ABCG5 ABCG8 SMAD3 PCSK9 ACTA2 AGXT FOXE3 hr>