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

B. Braun

Status and phase

Completed

Phase 3

Conditions

Restenosis

Stenosis

Treatments

Device: uncoated PTA catheter

Device: Paclitaxel coated balloon

Study type

Interventional

Funder types

Industry

Identifiers

NCT01970579

AAG-G-H-1214

Details and patient eligibility

About

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.

Enrollment

153 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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%
Target lesion in the SFA or popliteal artery (first two proximal segments)*.

* as far as applicable distance of the target lesion to a previously implanted stent should be about 1cm
Vessels must have adequate runoff with at least one vessel to the foot.
Treatment of max. two lesions is permitted.

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
Patient has presence or history of severe renal failure (GFR < 30ml/min) and is therefore not eligible for angiography.
Post transplantation of any organ or immune suppressive medication
Other disease to jeopardize follow-up (e.g. malignoma)
Addiction to any drug or to alcohol (WHO definition)
Patients with clinically significant aneurysmal disease of the popliteal, femoral or iliac artery and patients with history of clinically significant abdominal aortic aneurysm
Patients with any type of surgical/interventional procedures within 4 weeks prior to or planned after study intervention (if those may interfere with the peripheral study intervention and/or patient's ability to perform the follow up examinations)
Conditions which prevent the intake of the double anti-platelet therapy for two months
Patients with contraindication for drug-eluting balloon angioplasty given in the instruction for use
Patients under administrative or judicial custody (§20 Act on Medical Devices, Germany)
Strongly calcified lesions with circumferential presence of calcifications and a lesion length of > 4 cm
Chronic total occlusions longer than 10 cm
Lesion below the knee requiring treatment
Target lesion within a bypass graft
In-stent restenosis
Lesions treated with DCB
Concomitant use of atherectomy, cryoplasty or laser therapy
Inflow lesion (proximal to the study lesion) with flow limitation not being successfully treated prior to the study lesion