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

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

Study Overview

• Status: Completed
• Conditions: Restenosis; Occlusion; Stenosis
• Intervention / Treatment: Device: SeQuent Please OTW; Device: Eluvia Vascular Stent System; Device: Nitinol 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 Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Medizinische Universität Graz
• Germany
  • Arnsberg, Germany
    • Klinikum Arnsberg, Karolinen-Hospital
  • Bad Krozingen, Germany
    • Herzzentrum Bad Krozingen
  • Berlin, Germany
    • Vivantes Klinikum Neukölln
  • Berlin, Germany
    • Ihre-Radiologen Standort Franziskus-Krankenhaus
  • Berlin, Germany
    • Ihre-Radiologen Standort Jüdisches Krankenhaus
  • Flensburg, Germany
    • Diakonissenkrankenhaus Flensburg
  • Lübeck, Germany
    • Sana Kliniken Lübeck
  • Lübeck, Germany
    • Universitätklinikum Lübeck
  • Bayern
    • Rosenheim, Bayern, Germany
      • RoMed Klinikum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug coated balloon catheter; PTA with paclitaxel coated "SeQuent Please OTW"	Device: SeQuent Please OTW; Dilatation of occluded or highly stenosed vessel with paclitaxel-coated balloon catheter
Active Comparator: Drug coated stent; PTA with paclitaxel coated "Eluvia Vascular Stent System"	Device: Eluvia Vascular Stent System; Dilatation of occluded or highly stenosed vessel with paclitaxel-coated stent
Active Comparator: Uncoated stent; PTA with bare nitinol stent (as commonly used in site)	Device: Nitinol stent; Dilatation of occluded or highly stenosed vessel with uncoated bare nitinol stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent diameter stenosis at 1 year post intervention in successfully treated patients	by quantitative angiography	12 +/- 2 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event-free survival	absence from target lesion revascularization, amputations and death	6, 12, 24, 36 months
Walking distance	assessed in m and compared to baseline value	6, 12, 24, 36 months

Collaborators and Investigators

• Sponsor: InnoRa GmbH
• Collaborators: Boston Scientific Corporation; B. Braun Melsungen AG
• Investigators: Principal Investigator: Gunnar Tepe, MD, RoMed Klinikum Rosenheim

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2017
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: October 27, 2017
• First Submitted That Met QC Criteria: November 1, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: drug coated balloon; PAOD; drug coated stent; percutaneous transluminal angioplasty (PTA)
• Other Study ID Numbers: SP01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No