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Clinical Trial on Peripheral Arteries Treated With SeQuent® Please P Paclitaxel Coated Balloon Catheter

NCT01970579 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2020-03-30

No results posted yet for this study

Summary

The aim of the study is to assess the safety and efficacy of the paclitaxelreleasing balloon catheter SeQuent® Please P to treat de novo and restenotic lesions in the superficial femoral artery and the proximal two segments of the popliteal artery with reference diameters ≥ 4mm \& ≤ 7mm and lesion lengths ≥ 4 cm \& ≤ 27 cm. It is the intention of this trial to treat suitable target lesions with DCB only.

Conditions

  • Stenosis
  • Restenosis

Interventions

DEVICE

Paclitaxel coated balloon

* Treatment of target lesion with study balloon (coated). Diameter of treatment balloon = RVD * Each study balloon must only be used once (except postdilatation is necessary which may be done with the same balloon used for the initial dilatation) * Treatment balloon must be 20 mm longer than lesion length (to assure balloon overlap of 10 mm proximal and distal to lesion) * If two treatment balloons are necessary overlap between the balloon must be 10 mm * Inflation pressure 7-10 atm * Intraluminal defects or haziness should be treated with additional inflations and/or aggressive anti-platelet agents or bailout stenting

DEVICE

uncoated PTA catheter

* Treatment of target lesion with study balloon (uncoated). Diameter of treatment balloon = RVD * Each study balloon must only be used once (except postdilatation is necessary which may be done with the same balloon used for the initial dilatation) * Treatment balloon must be 20 mm longer than lesion length (to assure balloon overlap of 10 mm proximal and distal to lesion) * If two treatment balloons are necessary overlap between the balloon must be 10 mm * Inflation pressure 7-10 atm * Intraluminal defects or haziness should be treated with additional inflations and/or aggressive anti-platelet agents or bailout stenting.

Sponsors & Collaborators

  • B. Braun Melsungen AG

    lead INDUSTRY

Principal Investigators

  • Thomas Albrecht, MD · Vivantes Klinikum Neukölln, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-12-31
Completion
2019-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01970579 on ClinicalTrials.gov