CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Angiogram, Medtronic DCB (paclitaxel)/stent +1 moredevice
Likely dose
Paclitaxel-coated balloon (DCB) angioplasty with stentingAI-extracted
Key inclusion· 3
  • ✓Critical limb ischemia (CLI) in the target limb with Rutherford Category 5 or 6 (tissue loss)
  • ✓Scheduled for endovascular intervention for femoropopliteal occlusive or multilevel disease
  • ✓Target lesion(s) in SFA and/or popliteal arteries with ≥70% diameter stenosis
Key exclusion· 5
  • ✕Sensitivity or allergy to paclitaxel
  • ✕Aneurysm in the target vessel
  • ✕Acute thrombus in the target limb
  • ✕Immunosuppressed patients (transplant, chemotherapy, etc.)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02758847
NCT02758847N/ACompleted
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Evaluation of Paclitaxel in Patients With CLI (Critical Limb Ischemia) and Femoropopliteal Occlusive Disease Treated With DCB Angioplasty

Rabih A. Chaer·interventional·Posted May 3, 2016·Updated Apr 25, 2024

In Brief

A clinical study evaluating Angiogram, Medtronic DCB (paclitaxel)/stent and Angiogram, Bard DCB (paclitaxel)/stent for Ischemia. Completed, enrolled 50 participants across 1 site.

Detailed Summary

The use of drug coated balloon (DCB) in patients with critical limb ischemia (CLI) and tissue loss has recently raised some concerns after the IN.PACT deep trial using paclitaxel coated balloon angioplasty in the tibial arteries was terminated. The investigators objective is to establish the safety and efficacy of drug coated balloon (DCB) for femoropopliteal occlusive disease in patients with critical limb ischemia (CLI) and tissue loss. The investigators objective is to establish the safety and efficacy of drug coated balloon (DCB) for femoropopliteal occlusive disease in patients with critical limb ischemia (CLI) and tissue loss.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIschemia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedMay 3, 2016
Enrollment StartSep 1, 2016
Primary CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 10.2 years ago

Interventions

Angiogram, Medtronic DCB (paclitaxel)/stentdevice

Paclitaxel® coated balloons will be used for patients identified with Critical Limb Ischemia (CLI) and Tissue Loss. Each participant will receive angiogram with DCB (drug coated balloon)/stenting with wound debridement. 50% of subjects will receive an Angiogram, Medtronic DCB (paclitaxel)/stent. Tissue samples will be sent to pathology for specific staining to evaluate trace evidence of the drug paclitaxel.

Angiogram, Bard DCB (paclitaxel)/stentdevice

Paclitaxel® coated balloons will be used for patients identified with Critical Limb Ischemia (CLI) and Tissue Loss. 50% of subjects will receive 'Angiogram, Bard DCB (paclitaxel)/stent' . Tissue samples will be sent to pathology for specific staining to evaluate trace evidence of the drug paclitaxel.