Clinical trial NCT03332264: Sequent Please Drug Coated Balloons Versus Primary Stent Application in Long SFA Lesions
Official title: Sequent Please Drug Coated Balloons Versus Primary Stent Application in Long SFA Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stenosis
Occlusion
Restenosis
Keywords: PAOD
drug coated balloon
drug coated stent
percutaneous transluminal angioplasty (PTA)
Lead sponsor: InnoRa GmbH
Sponsor class: INDUSTRY
Collaborators: name: Boston Scientific Corporation
name: B. Braun Melsungen AG
First posted: 2017-11-06
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Vessel patency will be compared by quantitative angiography at 12 months in patients who have been treated either with paclitaxel coated balloon catheter, paclitaxel coated stent or bare metal stent in femoropopliteal arteries
Primary purpose: TREATMENT

Brief summary: Patients with peripheral artery disease will be treated with either drug coated balloon catheter, drug coated stent or uncoated stent.

Detailed description: Patients with chronic stenotic or occlusive atherosclerotic disease and lesions of at least 13 cm length in the SFA or Arteria poplitea segment 1 will be randomized to either treatment with paclitaxel coated balloon catheter, paclitaxel coated stent or bare nitinol stent. Vessel patency will be evaluated by quantitative angiography after 12 months. Clinical follow-ups will be done until 36 months post-intervention.

Eligibility criteria: Inclusion Criteria:

* PAOD and Rutherford classes 2 - 4 (pain-free walking distance \<500 m)
* eligible for peripheral revascularization by means of PTA
* peripheral lesions in the superficial femoral artery (SFA) and / or the PI-segment of the popliteal artery (A.pop.)
* minimum diameter stenosis of ≥70%
* treatment length at least 15 cm (lesion length at least 13 cm)
* maximum of lesions to be treated should be 2 (all treated lesions should be treated within the randomization to the study group, i.e. either coated balloon catheters or coated stents or bare nitinol stents); in case of two lesions matching the eligibility criteria, the one presenting the worst attributes (length and stenosis degree) should be chosen as target lesion
* long diffuse stenosis with or without occlusions may only be divided in separate lesions if non-stenotic (i.e. \<50% stenosis) segments in between the lesions extent to \>2 cm, otherwise vessel segments will be treated as a single extended lesion
* eligible for an operative vascular intervention in case of complications during the PTA

Exclusion Criteria:

* Rutherford class 1,5 or 6
* more than two stenotic lesions in the target vessel requiring treatment
* inflow lesion (proximal to the study lesion) with flow limitation not being successfully treated prior to the study lesion
* in-stent restenosis of the study lesion
* strongly calcified lesions with circumferential presence of calcifications and a lesion calcification length of \>4 cm
* reference vessel diameter \<4 mm and \>6 mm
* guide wire could not be successfully advanced across the lesion
* lesions below the knee requiring treatment
* target lesion is located in the PII-segment of the popliteal artery (A.pop.) or within a bypass graft
* acute thrombosis of the study lesion requiring lysis or thrombectomy prior to the treatment of the study lesion
* potential loss of leg due to critical or acute ischemia
* no patent distal run-off vessel
* medical reason against double anti-platelet therapy in anti-coagulated patient, e.g., receiving coumarine or conditions which prevent the intake of the double anti-platelet therapy for two months
* female patient who is pregnant or lactating
* under 18 years of age
* patients under administrative or judicial custody (§20 Act on medical Devices, Germany)
* expected life span of less than 24 months

Primary outcomes:
measure: Percent diameter stenosis at 1 year post intervention in successfully treated patients
timeFrame: 12 +/- 2 months
Secondary outcomes:
measure: Late Lumen Loss
timeFrame: 12 months
measure: Binary restenosis
timeFrame: 6,12, 24, 36 months
measure: Target lesion revascularization
timeFrame: 6, 12, 24, 36 months
Other outcomes:
measure: Event-free survival
timeFrame: 6, 12, 24, 36 months
measure: Walking distance
timeFrame: 6, 12, 24, 36 months
Locations:
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Rosenheim
country: Germany
facility: RoMed Klinikum
state: Bayern
city: Arnsberg
country: Germany
facility: Klinikum Arnsberg, Karolinen-Hospital
city: Bad Krozingen
country: Germany
facility: Herzzentrum Bad Krozingen
city: Berlin
country: Germany
facility: Ihre-Radiologen Standort Franziskus-Krankenhaus
city: Berlin
country: Germany
facility: Ihre-Radiologen Standort Jüdisches Krankenhaus
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln
city: Flensburg
country: Germany
facility: Diakonissenkrankenhaus Flensburg
city: Lübeck
country: Germany
facility: SANA Kliniken Lübeck
city: Lübeck
country: Germany
facility: Universitätklinikum Lübeck
Study officials:
affiliation: RoMed Klinikum Rosenheim
name: Gunnar Tepe, MD
role: PRINCIPAL_INVESTIGATOR
References: