Sequent Please Drug Coated Balloons Versus Primary Stent Application in Long SFA Lesions

Not Applicable

Completed

• Conditions: Stenosis; Occlusion; Restenosis
• Interventions: Device: Nitinol stent; Device: SeQuent Please OTW; Device: Eluvia Vascular Stent System

• Registration Number: NCT03332264
• Lead Sponsor: InnoRa GmbH

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.

Study Timeline

• Study Start: 2017-03-30
• Study First Submitted: 2017-10-27
• Study First Submitted QC: 2017-11-01
• Study First Posted: 2017-11-06
• Primary Completion: 2022-01-31
• Study Completion: 2023-12-12
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uncoated stent	Nitinol stent	PTA with bare nitinol stent (as commonly used in site)
Drug coated balloon catheter	SeQuent Please OTW	PTA with paclitaxel coated "SeQuent Please OTW"
Drug coated stent	Eluvia Vascular Stent System	PTA with paclitaxel coated "Eluvia Vascular Stent System"

Primary Outcome Measures

Name	Time	Method
Percent diameter stenosis at 1 year post intervention in successfully treated patients	12 +/- 2 months	by quantitative angiography

Secondary Outcome Measures

Name	Time	Method
Late Lumen Loss	12 months	by quantitative angiography
Binary restenosis	6,12, 24, 36 months	by DUS
Target lesion revascularization	6, 12, 24, 36 months	number of re-interventions at target lesion

Trial Locations

Locations (10)

Diakonissenkrankenhaus Flensburg; 🇩🇪 Flensburg, Germany

Medizinische Universität Graz; 🇦🇹 Graz, Austria

Herzzentrum Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

RoMed Klinikum; 🇩🇪 Rosenheim, Bayern, Germany

Ihre-Radiologen Standort Jüdisches Krankenhaus; 🇩🇪 Berlin, Germany

Klinikum Arnsberg, Karolinen-Hospital; 🇩🇪 Arnsberg, Germany

Vivantes Klinikum Neukölln; 🇩🇪 Berlin, Germany

Ihre-Radiologen Standort Franziskus-Krankenhaus; 🇩🇪 Berlin, Germany

Universitätklinikum Lübeck; 🇩🇪 Lübeck, Germany

SANA Kliniken Lübeck; 🇩🇪 Lübeck, Germany