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Report for Clinical Trial NCT02953496

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 1 Multi-Center, Dose-Escalation Study of Vonapanitase Administered Percutaneously to the Superficial Femoral or Popliteal Artery in Patients With Peripheral Artery Disease

The research study is designed to assess the technical feasibility and safety of percutaneous administration of vonapanitase to the superficial femoral or popliteal artery in patients with PAD.

NCT02953496 Peripheral Artery Disease
MeSH: Peripheral Arterial Disease
HPO: Peripheral arterial stenosis

1 Interventions

Name: vonapanitase

Description: Vonapanitase will be administered to the target lesion of the SFA or PA via percutaneous needle injection under ultrasound guidance.

Type: Drug

vonapanitase


Primary Outcomes

Description: Safety assessments include physical exams, duplex Doppler ultrasound 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 percutaneous injection

Time: Intraprocedural

Other Outcomes

Measure: Peak systolic velocity ratio [PSVR]

Time: 14 days and 6 months following study drug administration

Measure: Minimum lumen diameter [MLD]

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: 6-minute walk test [6MWT]

Time: 14 days and 6 months following study drug administration

Purpose: Treatment

Single Group Assignment


There is one SNP

SNPs


1 G20210A

7. Known hypercoagulable state (e.g., protein C deficiency, factor V Leiden mutation, prothrombin G20210A mutation). --- G20210A ---



HPO Nodes


HPO:
Peripheral arterial stenosis
Genes 31
AGXT MPL LDLRAP1 LDLR FBN1 APOE THPO APOB MAT2A ABCG8 MYH11 TGFB2 LMNA ELN FOXE3 ABCC6 SMAD4 JAK2 TGFBR2 MFAP5 ELN SMAD3 MYH11 LOX PCSK9 ACTA2 TGFB3 PRKG1 TGFBR1 MYLK ABCG5