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

NCT ID: NCT01970579

Last Updated: 2020-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 153 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2019-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Paclitaxel coated balloon

Group Type: EXPERIMENTAL

Paclitaxel coated balloon

Intervention Type: 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

uncoated PTA catheter

Group Type: ACTIVE_COMPARATOR

uncoated PTA catheter

Intervention Type: 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.

Interventions

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

Intervention Type: 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.

Intervention Type: DEVICE

Other Intervention Names

SeQuent® Please P; Drug coated balloon; POBA

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

B. Braun Melsungen AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Albrecht, MD

Role: PRINCIPAL_INVESTIGATOR

Vivantes Klinikum Neukölln, Berlin, Germany

Locations

Universitäts-Herzzentrum Freiburg Bad Krozingen

Bad Krozingen, , Germany

Vivantes Klinikum Neukölln

Berlin, , Germany

Ev. Krankenhaus Hubertus

Berlin, , Germany

Klinikum der Otto-von-Guericke-Universität Magdeburg

Magdeburg, , Germany

Klinikum Magdeburg

Magdeburg, , Germany

Deutsches Herzzentrum München

München, , Germany

RoMed Klinikum Rosenheim

Rosenheim, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 29589098 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28660441 (View on PubMed)

Other Identifiers

AAG-G-H-1214

Identifier Type: -

Identifier Source: org_study_id