Clinical trial NCT01970579: Clinical Trial on Peripheral Arteries Treated With SeQuent® Please P Paclitaxel Coated Balloon Catheter
Official title: Clinical Trial on Peripheral Arteries Treated With SeQuent® Please P Paclitaxel Coated Balloon Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Stenosis
Restenosis
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2013-10-28
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Late Lumen Loss
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Krozingen
country: Germany
facility: Universitäts-Herzzentrum Freiburg Bad Krozingen
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln
city: Berlin
country: Germany
facility: Ev. Krankenhaus Hubertus
city: Magdeburg
country: Germany
facility: Klinikum der Otto-von-Guericke-Universität Magdeburg
city: Magdeburg
country: Germany
facility: Klinikum Magdeburg
city: München
country: Germany
facility: Deutsches Herzzentrum München
city: Rosenheim
country: Germany
facility: RoMed Klinikum Rosenheim
Study officials:
affiliation: Vivantes Klinikum Neukölln, Berlin, Germany
name: Thomas Albrecht, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.