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Clinical Trials/CTRI/2015/11/006374
CTRI/2015/11/006374OtherPhase 4

A prospective, phase 4, open label, multicenter study to evaluate the Zilver PTX Drug-Eluting Peripheral Stent in patients with lesions of the above-the-knee femoropopliteal artery in India ( Zilver PTX VII,India)

Cook Incorporated0 sites50 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
Phase 4
Status
Other
Enrollment
50
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Pms

Eligibility Criteria

Inclusion Criteria

  • •1. Symptoms of peripheral arterial disease corresponding to Rutherford
  • •Classification 2-4
  • •2. Stenotic ( >50% diameter stenosis) or occluded lesion of the above-the knee
  • •femoropopliteal artery
  • •3. Reference vessel diameter of 4-7 mm

Exclusion Criteria

  • •1. Less than 18 years old
  • •2. Unwilling or unable to sign and date the informed consent
  • •3. Pregnant, lactating, or planning to become pregnant in the next 5 years
  • •4. Unwilling or unable to comply with follow-up schedule
  • •5. Simultaneously participating in another investigational drug or device study in which the follow-up phase for that studyâ??s primary endpoint has not been completed 30 days or more prior to being enrolled in this study.
  • •6. Presence of study limb wound (Rutherford Classification 5-6)
  • •7. Any interventional treatment within 30 days prior to the study procedure
  • •8. Planned surgical or interventional procedure within 30 days after the study procedure
  • •9. Planned procedure involving arterial interventional treatment of the study leg
  • •within 6 months after the clinical study procedure
  • •10. Medical condition or disorder that would limit life expectancy to less than 12
  • •months, or that may cause noncompliance with the study plan or confound the data analysis
  • •11. Known hypersensitivity or contraindication to study products that, in the opinion of the investigator, cannot be adequately pre-medicated; study products include nitinol, paclitaxel, dual antiplatelet therapy, and contrast agent
  • •12. Current systemic or local infection that could affect the study outcomes
  • •13. Previous stent in the target vessel
  • •14. Bypass graft with an anastomosis in the target vessel
  • •15. Myocardial infarction within the last 90 days
  • •16. Is in chronic renal failure, or is on hemodialysis or chronic peritoneal dialysis
  • •17. Uncontrolled or poorly controlled diabetes
  • •18. History of bleeding diathesis or coagulopathy or will refuse blood transfusions
  • •19. History of aortic aneurysm 5 cm (treated or untreated)
  • •20. History of iliac aneurysm 2 cm (treated or untreated).
  • •21. Lesion length 140 mm
  • •22. Untreated stenosis ( 50%) or occlusion of inflow tract (i.e., proximal ipsilateral,
  • •iliofemoral, or aortic lesions). Inflow tract may be treated during the study procedure.
  • •23. Untreated stenosis ( 50%) or occlusion of all runoff vessels (i.e., anterior tibial,
  • •posterior tibial and peroneal). Runoff vessel(s) may be treated during the study
  • •procedure; treatment must be performed prior to treating the target lesion and
  • •result in less than eqal to 30% residual stenosis of at least one runoff vessel.
  • •24. Angiographically-evident thrombus in the target lesion
  • •25. Lesions requiring atherectomy (or ablative devices), cutting balloons, or any
  • •other advanced device to facilitate stent delivery.

Investigators

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