Clinical Post Market Clinical Follow-up (PMCF) on Peripheral Arteries Treated With SeQuent® Please Over The Wire (OTW) (CONSEQUENT)

CONSEQUENT ALL COMERS Clinical PMCF on Peripheral Arteries Treated With SeQuent® Please OTW Paclitaxel Coated Balloon Catheter in an All Comer Patient Population

The aim of the study is to assess the safety and efficacy of the paclitaxel-releasing balloon catheter SeQuent® Please OTW to treat de novo and restenotic lesions in peripheral arteries. It is the intention of this trial to treat suitable target lesions with drug coated balloon (DCB) only.

Study Overview

• Status: Active, not recruiting
• Conditions: Peripheral Arterial Occlusive Disease
• Intervention / Treatment: Procedure: drug coated balloon angioplasty; Device: SeQuent® Please OTW Paclitaxel Coated Balloon Catheter

Detailed Description

This study is an non-randomized, prospective, multi-center, non-interventional study (NIS=registry, for Germany: §23b MPG)

• Study Type: Observational
• Enrollment (Actual): 960

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10713
    • St. Gertrauden Krankenhaus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with peripheral artery occlusive disease (PAOD)

Description

Inclusion Criteria (patient):

• Willingness to treat the target lesion according to the DCB only concept
• Patients in Rutherford classes 2 through 5
• Patients eligible for peripheral revascularization by means of Percutaneous Transluminal Angioplasty (PTA)
• Patients must be 18 years of age
• Patients who are mentally and linguistically able to understand the aim of the study and to show sufficient compliance in the following study protocol
• Patients must agree to undergo at least the 12-month clinical follow-up
• Patient is able to verbally acknowledge an understanding of the associated risks, benefits, and treatment alternatives to therapeutic options of this trial, e.g. balloon angioplasty by means of the paclitaxel-eluting PTA-balloon catheter or other suitable devices. Patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document.

Inclusion Criteria (lesion):

• Peripheral lesions in peripheral arteries above and below the knee with reference vessel diameters between 1.5 and 8.0 mm, lesion lengths ≥ 2 cm and ≤ 27 cm as angiographically documented*
• Diameter stenosis pre-procedure must be 70%
• Target lesion above and below the knee
• Vessels must have adequate runoff with at least one vessel to the foot. *Lesions separated by less than 2 cm are considered as one lesion

Exclusion Criteria (all comers):

• Patient not suitable for revascularization by interventional means

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Revascularization Rate	rate of target lesion revascularization (interventional, surgical)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Revascularization Rate (TLR)	Target Lesion Revascularization Rate at 24 months* to establish a 'freedom from TLR' Kaplan-Meier curve	24 months
Procedural success	Procedural success to pass and treat the lesions (remaining stenosis is 30 %)	1 day
Ankle Brachial Index (ABI)	ankle brachial index	12 months
Ankle Brachial Index (ABI)	ankle brachial index	24 months
Ankle Brachial Index (ABI)	ankle brachial index	3 years
Ankle Brachial Index (ABI)	ankle brachial index	5 years
Maximum Walking Distance (MWD)	maximum walking distance under standardized conditions	12 months
Maximum Walking Distance (MWD)	maximum walking distance under standardized conditions	24 months
Maximum Walking Distance (MWD)	maximum walking distance under standardized conditions	3 years
Maximum Walking Distance (MWD)	maximum walking distance under standardized conditions	5 years
Patency rate	Patency rates as observed using non-invasive Duplex ultrasound	12 months
Patency rate	Patency rates as observed using non-invasive Duplex ultrasound	24 months
Patency rate	Patency rates as observed using non-invasive Duplex ultrasound	3 years
Patency rate	Patency rates as observed using non-invasive Duplex ultrasound	5 years
Rutherford classifications per group at all follow-up intervals	Rutherford classifications per group at all follow-up intervals	12/24 months and 3/5 years
Rutherford classification distribution change at all follow-up intervals	Rutherford classification distribution change at all follow-up intervals	12/24 months and 3/5 years
Amputation rate	Amputation rate at 12/24 months and 3/5 years and 'freedom from amputation' Kaplan-Meier curve	12/24 months and 3/5 years

Collaborators and Investigators

• Sponsor: B. Braun Melsungen AG
• Investigators: Principal Investigator: Ralf Langhoff, MD, St. Gertrauden Krankenhaus, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2015
• Primary Completion (ACTUAL): December 1, 2018
• Study Completion (ANTICIPATED): January 1, 2025

Study Registration Dates

• First Submitted: February 26, 2015
• First Submitted That Met QC Criteria: May 29, 2015
• First Posted (ESTIMATE): June 2, 2015

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: AAG-O-H-1309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED