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

NCT ID: NCT02460042

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 960 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2025-12-31

Brief 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.

Detailed Description

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

Conditions

Peripheral Arterial Occlusive Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

drug coated balloon angioplasty

percutaneous transluminal angioplasty with peripheral balloon catheters

Intervention Type: PROCEDURE

SeQuent® Please OTW Paclitaxel Coated Balloon Catheter

Intervention Type: DEVICE

Other Intervention Names

peripheral drug eluting balloon

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• Patient not suitable for revascularization by interventional means

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

Sponsors

B. Braun Melsungen AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ralf Langhoff, MD

Role: PRINCIPAL_INVESTIGATOR

St. Gertrauden Krankenhaus, Berlin, Germany

Locations

St. Gertrauden Krankenhaus

Berlin, , Germany

Countries

Germany

Other Identifiers

AAG-O-H-1309

Identifier Type: -

Identifier Source: org_study_id