Clinical Trial on Peripheral Arteries Treated With SeQuent® Please P Paclitaxel Coated Balloon Catheter

B. Braun Melsungen AG7 sites in 1 country153 target enrollmentOctober 2013

ConditionsStenosis Restenosis

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Stenosis
Sponsor: B. Braun Melsungen AG
Enrollment: 153
Locations: 7
Primary Endpoint: Late Lumen Loss
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of the study is to assess the safety and efficacy of the paclitaxelreleasing balloon catheter SeQuent® Please P to treat de novo and restenotic lesions in the superficial femoral artery and the proximal two segments of the popliteal artery with reference diameters ≥ 4mm & ≤ 7mm and lesion lengths ≥ 4 cm & ≤ 27 cm. It is the intention of this trial to treat suitable target lesions with DCB only.

Registry

clinicaltrials.gov

Start Date

October 2013

End Date

December 2019

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

B. Braun Melsungen AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Willingness to treat the target lesion according to the DCB only concept
•Patients in Rutherford classes 2 through 4 (corresponding to Fontaine stage IIb to III)
•Patients eligible for peripheral revascularization by means of 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 following the study protocol
•Patients must agree to undergo the 6-month angiographic and clinical follow-up
•Patients must agree to undergo the 1 and 2 year 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. The patients, by providing their informed consent, agree to these risks and benefits as stated in the patient informed consent document.
•Peripheral lesions in the native SFA or popliteal artery with reference vessel diameters between ≥ 4.0 and ≤ 7.0 mm, lesions lengths ≥ 4 cm and ≤ 27 cm as angiographically documented
•Diameter stenosis pre-procedure must be ≥ 70%

Exclusion Criteria

•Patients with Rutherford class 5 or 6
•Women who are known or suspected to be pregnant. Hence, patients will be advised to use an adequate birth control method up to and including the 6-month follow-up.
•Patients with an expected life span of less than 24 months
•Patients with bleeding diathesis in whom anticoagulation or anti-platelet medication is contraindicated
•Patients who had a cerebral stroke \< 6 months prior to the procedure
•Patients with unstable angina pectoris
•Patients with acute myocardial infarction within the past 2 weeks
•Patient participates in other clinical trials involving any investigational device or drug that interfere with the effects to be studied in this trial.
•Interventional treatment at the contralateral leg within 2 weeks prior to or after the study intervention
•Untreated hyperthyroidism