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

NCT02460042 | Active Not Recruiting DMC

• 1 other identifier: AAG-O-H-1309
• Study Type: observational
• Target: 960
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Arterial Occlusive Disease

Outcome Measures

Primary Outcomes (1)

• Target Lesion Revascularization Rate

  rate of target lesion revascularization (interventional, surgical)

  12 months

Secondary Outcomes (17)

• Target Lesion Revascularization Rate (TLR)

  24 months

• Procedural success

  1 day

• Ankle Brachial Index (ABI)

  12 months

• Ankle Brachial Index (ABI)

  24 months

• Ankle Brachial Index (ABI)

  3 years

Interventions

drug coated balloon angioplasty PROCEDURE

percutaneous transluminal angioplasty with peripheral balloon catheters

Also known as: peripheral drug eluting balloon

SeQuent® Please OTW Paclitaxel Coated Balloon Catheter DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with peripheral artery occlusive disease (PAOD)

You may qualify if:

• 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

You may not qualify if:

• Patient not suitable for revascularization by interventional means

Sponsors & Collaborators

• B. Braun Melsungen AG: lead

Study Sites (1)

St. Gertrauden Krankenhaus

Berlin, 10713, Germany

Location

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Study Officials

• Ralf Langhoff, MD

  St. Gertrauden Krankenhaus, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: June 2, 2015
• Study Start: May 1, 2015
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-02

Locations

DE (1)