SNPMiner Trials by Shray Alag


SNPMiner Trials: Clinical Trial Report

Report for Clinical Trial NCT02956993

Developed by Shray Alag, 2019.
SNP Clinical Trial Gene

A Phase 1, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study of Vonapanitase Administered Following Angioplasty of a Distal Popliteal, Tibial or Peroneal Artery in Patients With Peripheral Artery Disease

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.

NCT02956993 Peripheral Artery Disease
MeSH: Peripheral Arterial Disease
HPO: Peripheral arterial stenosis

2 Interventions

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