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

NCT ID: NCT03332264

Last Updated: 2024-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-30
• Study Completion Date: 2023-12-12

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.

Conditions

Stenosis; Occlusion; Restenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Drug coated balloon catheter

PTA with paclitaxel coated "SeQuent Please OTW"

Group Type: EXPERIMENTAL

SeQuent Please OTW

Intervention Type: DEVICE

Dilatation of occluded or highly stenosed vessel with paclitaxel-coated balloon catheter

Drug coated stent

PTA with paclitaxel coated "Eluvia Vascular Stent System"

Group Type: ACTIVE_COMPARATOR

Eluvia Vascular Stent System

Intervention Type: DEVICE

Dilatation of occluded or highly stenosed vessel with paclitaxel-coated stent

Uncoated stent

PTA with bare nitinol stent (as commonly used in site)

Group Type: ACTIVE_COMPARATOR

Nitinol stent

Intervention Type: DEVICE

Dilatation of occluded or highly stenosed vessel with uncoated bare nitinol stent

Interventions

SeQuent Please OTW

Dilatation of occluded or highly stenosed vessel with paclitaxel-coated balloon catheter

Intervention Type: DEVICE

Eluvia Vascular Stent System

Dilatation of occluded or highly stenosed vessel with paclitaxel-coated stent

Intervention Type: DEVICE

Nitinol stent

Dilatation of occluded or highly stenosed vessel with uncoated bare nitinol stent

Intervention Type: DEVICE

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

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

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

B. Braun Melsungen AG

INDUSTRY

Sponsor Role: collaborator

InnoRa GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gunnar Tepe, MD

Role: PRINCIPAL_INVESTIGATOR

RoMed Klinikum Rosenheim

Locations

Medizinische Universität Graz

Graz, , Austria

RoMed Klinikum

Rosenheim, Bavaria, Germany

Klinikum Arnsberg, Karolinen-Hospital

Arnsberg, , Germany

Herzzentrum Bad Krozingen

Bad Krozingen, , Germany

Ihre-Radiologen Standort Franziskus-Krankenhaus

Berlin, , Germany

Ihre-Radiologen Standort Jüdisches Krankenhaus

Berlin, , Germany

Vivantes Klinikum Neukölln

Berlin, , Germany

Diakonissenkrankenhaus Flensburg

Flensburg, , Germany

SANA Kliniken Lübeck

Lübeck, , Germany

Universitätklinikum Lübeck

Lübeck, , Germany

Countries

Austria; Germany

Other Identifiers

SP01

Identifier Type: -

Identifier Source: org_study_id