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

Peripheral Arterial Occlusive Disease Clinical Trial

— CONSEQUENT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02460042
• Other study ID #: AAG-O-H-1309
• Status: Active, not recruiting
• Start date: May 2015
• Est. completion date: January 2025

Study information

• Verified date: February 2023
• Source: B. Braun Melsungen AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 960
• Est. completion date: January 2025
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Occlusive Disease

Intervention

Procedure:
• drug coated balloon angioplasty
percutaneous transluminal angioplasty with peripheral balloon catheters

Device:
• SeQuent® Please OTW Paclitaxel Coated Balloon Catheter

Locations

Country	Name	City	State
Germany	St. Gertrauden Krankenhaus	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
B. Braun Melsungen AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Target Lesion Revascularization Rate	rate of target lesion revascularization (interventional, surgical)	12 months
Secondary	Target Lesion Revascularization Rate (TLR)	Target Lesion Revascularization Rate at 24 months* to establish a 'freedom from TLR' Kaplan-Meier curve	24 months
Secondary	Procedural success	Procedural success to pass and treat the lesions (remaining stenosis is 30 %)	1 day
Secondary	Ankle Brachial Index (ABI)	ankle brachial index	12 months
Secondary	Ankle Brachial Index (ABI)	ankle brachial index	24 months
Secondary	Ankle Brachial Index (ABI)	ankle brachial index	3 years
Secondary	Ankle Brachial Index (ABI)	ankle brachial index	5 years
Secondary	Maximum Walking Distance (MWD)	maximum walking distance under standardized conditions	12 months
Secondary	Maximum Walking Distance (MWD)	maximum walking distance under standardized conditions	24 months
Secondary	Maximum Walking Distance (MWD)	maximum walking distance under standardized conditions	3 years
Secondary	Maximum Walking Distance (MWD)	maximum walking distance under standardized conditions	5 years
Secondary	Patency rate	Patency rates as observed using non-invasive Duplex ultrasound	12 months
Secondary	Patency rate	Patency rates as observed using non-invasive Duplex ultrasound	24 months
Secondary	Patency rate	Patency rates as observed using non-invasive Duplex ultrasound	3 years
Secondary	Patency rate	Patency rates as observed using non-invasive Duplex ultrasound	5 years
Secondary	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
Secondary	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
Secondary	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