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

March 27, 2020 updated by: B. Braun Melsungen AG
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bad Krozingen, Germany, 79189
        • Universitäts-Herzzentrum Freiburg Bad Krozingen
      • Berlin, Germany, 12351
        • Vivantes Klinikum Neukölln
      • Berlin, Germany, 14129
        • Ev. Krankenhaus Hubertus
      • Magdeburg, Germany, 39120
        • Klinikum der Otto-von-Guericke-Universität Magdeburg
      • Magdeburg, Germany, 39130
        • Klinikum Magdeburg
      • München, Germany, 80636
        • Deutsches Herzzentrum München
      • Rosenheim, Germany, 83022
        • RoMed Klinikum Rosenheim

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Willingness to treat the target lesion according to the DCB only concept
  • Patients in Rutherford classes 2 through 4 (corresponding to Fontaine stage IIb to III)
  • Patients eligible for peripheral revascularization by means of PTA
  • Patients must be ≥ 18 years of age
  • Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in following the study protocol
  • Patients must agree to undergo the 6-month angiographic and clinical follow-up
  • Patients must agree to undergo the 1 and 2 year clinical follow-up
  • Patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial. The patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document.
  • Peripheral lesions in the native SFA or popliteal artery with reference vessel diameters between ≥ 4.0 and ≤ 7.0 mm, lesions lengths ≥ 4 cm and ≤ 27 cm as angiographically documented
  • Diameter stenosis pre-procedure must be ≥ 70%

  • Target lesion in the SFA or popliteal artery (first two proximal segments)*.

    * as far as applicable distance of the target lesion to a previously implanted stent should be about 1cm

  • Vessels must have adequate runoff with at least one vessel to the foot.
  • Treatment of max. two lesions is permitted.

Exclusion Criteria:

  • Patients with Rutherford class 5 or 6
  • Women who are known or suspected to be pregnant. Hence, patients will be advised to use an adequate birth control method up to and including the 6-month follow-up.
  • Patients with an expected life span of less than 24 months
  • Patients with bleeding diathesis in whom anticoagulation or anti-platelet medication is contraindicated
  • Patients who had a cerebral stroke < 6 months prior to the procedure
  • Patients with unstable angina pectoris
  • Patients with acute myocardial infarction within the past 2 weeks
  • Patient participates in other clinical trials involving any investigational device or drug that interfere with the effects to be studied in this trial.
  • Interventional treatment at the contralateral leg within 2 weeks prior to or after the study intervention
  • Untreated hyperthyroidism
  • Patient has presence or history of severe renal failure (GFR < 30ml/min) and is therefore not eligible for angiography.
  • Post transplantation of any organ or immune suppressive medication
  • Other disease to jeopardize follow-up (e.g. malignoma)
  • Addiction to any drug or to alcohol (WHO definition)
  • Patients with clinically significant aneurysmal disease of the popliteal, femoral or iliac artery and patients with history of clinically significant abdominal aortic aneurysm
  • Patients with any type of surgical/interventional procedures within 4 weeks prior to or planned after study intervention (if those may interfere with the peripheral study intervention and/or patient's ability to perform the follow up examinations)
  • Conditions which prevent the intake of the double anti-platelet therapy for two months
  • Patients with contraindication for drug-eluting balloon angioplasty given in the instruction for use
  • Patients under administrative or judicial custody (§20 Act on Medical Devices, Germany)
  • Strongly calcified lesions with circumferential presence of calcifications and a lesion length of > 4 cm
  • Chronic total occlusions longer than 10 cm
  • Lesion below the knee requiring treatment
  • Target lesion within a bypass graft
  • In-stent restenosis
  • Lesions treated with DCB
  • Concomitant use of atherectomy, cryoplasty or laser therapy
  • Inflow lesion (proximal to the study lesion) with flow limitation not being successfully treated prior to the study lesion

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Paclitaxel coated balloon
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
Other Names:
  • SeQuent® Please P
  • Drug coated balloon
Active Comparator: uncoated PTA catheter
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.
Other Names:
  • POBA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Late Lumen Loss
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

B. Braun Melsungen AG

Investigators

  • Principal Investigator: Thomas Albrecht, MD, Vivantes Klinikum Neukölln, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

October 23, 2013

First Submitted That Met QC Criteria

October 23, 2013

First Posted (Estimate)

October 28, 2013

Study Record Updates

Last Update Posted (Actual)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-G-H-1214

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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