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

NCT01970579 | Completed Phase 3 DMC

• 1 other identifier: AAG-G-H-1214
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 7

Brief 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

Outcome Measures

Primary Outcomes (1)

• Late Lumen Loss

  6 months

Study Arms (2)

Paclitaxel coated balloon

EXPERIMENTAL

Device: Paclitaxel coated balloon

uncoated PTA catheter

ACTIVE COMPARATOR

Device: uncoated PTA catheter

Interventions

Paclitaxel coated balloon DEVICE

* 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

Also known as: SeQuent® Please P, Drug coated balloon

Paclitaxel coated balloon

uncoated PTA catheter DEVICE

* 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.

Also known as: POBA

uncoated PTA catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• B. Braun Melsungen AG: lead

Study Sites (7)

Universitäts-Herzzentrum Freiburg Bad Krozingen

Bad Krozingen, 79189, Germany

Location

Vivantes Klinikum Neukölln

Berlin, 12351, Germany

Location

Ev. Krankenhaus Hubertus

Berlin, 14129, Germany

Location

Klinikum der Otto-von-Guericke-Universität Magdeburg

Magdeburg, 39120, Germany

Location

Klinikum Magdeburg

Magdeburg, 39130, Germany

Location

Deutsches Herzzentrum München

München, 80636, Germany

Location

RoMed Klinikum Rosenheim

Rosenheim, 83022, Germany

Location

Related Publications (2)

• Albrecht T, Waliszewski M, Roca C, Redlich U, Tautenhahn J, Pech M, Halloul Z, Gogebakan O, Meyer DR, Gemeinhardt I, Zeller T, Muller-Hulsbeck S, Ott I, Tepe G. Two-Year Clinical Outcomes of the CONSEQUENT Trial: Can Femoropopliteal Lesions be Treated with Sustainable Clinical Results that are Economically Sound? Cardiovasc Intervent Radiol. 2018 Jul;41(7):1008-1014. doi: 10.1007/s00270-018-1940-1. Epub 2018 Mar 27.

  PMID: 29589098 DERIVED

• Tepe G, Gogebakan O, Redlich U, Tautenhahn J, Ricke J, Halloul Z, Meyer DR, Waliszewski M, Schnorr B, Zeller T, Muller-Hulsbeck S, Ott I, Albrecht T. Angiographic and Clinical Outcomes After Treatment of Femoro-Popliteal Lesions with a Novel Paclitaxel-Matrix-Coated Balloon Catheter. Cardiovasc Intervent Radiol. 2017 Oct;40(10):1535-1544. doi: 10.1007/s00270-017-1713-2. Epub 2017 Jun 28.

  PMID: 28660441 DERIVED

MeSH Terms

Conditions

Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Albrecht, MD

  Vivantes Klinikum Neukölln, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: October 28, 2013
• Study Start: October 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2019
• Last Updated: March 30, 2020

Record last verified: 2020-03

Locations

DE (7)