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

Stenosis Clinical Trial

— SPORTS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03332264
• Other study ID #: SP01
• Status: Completed
• Phase: N/A
• Start date: March 30, 2017
• Est. completion date: December 12, 2023

Study information

• Verified date: February 2024
• Source: InnoRa GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: December 12, 2023
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Occlusion
• Restenosis
• Stenosis

Intervention

Device:
• SeQuent Please OTW
Dilatation of occluded or highly stenosed vessel with paclitaxel-coated balloon catheter
• Eluvia Vascular Stent System
Dilatation of occluded or highly stenosed vessel with paclitaxel-coated stent
• Nitinol stent
Dilatation of occluded or highly stenosed vessel with uncoated bare nitinol stent

Locations

Country	Name	City	State
Austria	Medizinische Universität Graz	Graz
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	RoMed Klinikum	Rosenheim	Bayern

Sponsors (3)

Lead Sponsor	Collaborator
InnoRa GmbH	B. Braun Melsungen AG, Boston Scientific Corporation

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Event-free survival	absence from target lesion revascularization, amputations and death	6, 12, 24, 36 months
Other	Walking distance	assessed in m and compared to baseline value	6, 12, 24, 36 months
Primary	Percent diameter stenosis at 1 year post intervention in successfully treated patients	by quantitative angiography	12 +/- 2 months
Secondary	Late Lumen Loss	by quantitative angiography	12 months
Secondary	Binary restenosis	by DUS	6,12, 24, 36 months
Secondary	Target lesion revascularization	number of re-interventions at target lesion	6, 12, 24, 36 months