Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03071146
Other study ID # BPV-16-004
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 15, 2017
Est. completion date May 31, 2018

Study information

Verified date August 2018
Source C. R. Bard
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The medical device being examined in this study is the Bard® LifeStent® 5F Vascular Stent System. It is intended for use in patients who suffer from peripheral artery disease (PAD). PAD is generally associated with blocked arteries of the legs. The superficial femoral artery (SFA) and popliteal artery are common locations for this problem to develop. The patient may experience pain or discomfort in the leg that occurs when walking or have other complications associated with wound healing. The purpose of this study is to collect information to assess the deliverability, clinical utility, safety and effectiveness of the Bard® LifeStent® 5F Vascular Stent System.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 31, 2018
Est. primary completion date May 4, 2017
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria:

- The subject or legal representative has been informed of the nature of the evaluation, agrees to its provisions, and has signed the informed consent form (ICF).

- Subject agrees to comply with the protocol-mandated follow-up procedures and visits.

- The subject is = 21 years of age.

- The subject has lifestyle-limiting claudication to mild tissue loss defined as: Rutherford Category 2-5 (moderate claudication to minor tissue loss).

- The target lesion(s) has angiographic evidence of a hemodynamically relevant stenosis or restenosis =50% or occlusion of the SFA and/or popliteal artery (by visual estimate) and is amenable to PTA and stenting.

- The target vessel reference diameter will be (by visual estimate) appropriate for treatment with available stent diameters of 5.0, 6.0 and 7.0 mm.

- A total of two stents may be used to treat a target lesion. Overlapping is allowed.

- There is angiographic evidence of at least one vessel runoff to the foot (at the level of the malleolus).

Exclusion Criteria:

- The subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with the study follow-up procedure and visits.

- The subject has claudication or critical limb ischemia described as Rutherford Category 0 (asymptomatic), 1 (mild claudication), or 6 (major tissue loss).

- The subject has a known contraindication (including allergic reaction) or sensitivity to nickel, titanium or tantalum.

- The subject has a known allergy of hypersensitivity to contrast media which cannot be adequately pre-medicated.

- The subject has a known uncontrolled blood coagulation/bleeding disorder.

- The subject has concomitant renal failure with a creatinine of >2.5 mg/dL.

- The subject has concomitant hepatic insufficiency, thrombophlebitis, uremia, systemic lupus erythematosus (SLE), or deep vein thrombosis (DVT) at the time of the study procedure.

- The subject is receiving dialysis or immunosuppressive therapy.

- The subject is diagnosed with septicemia at the time of the study procedure.

- The subject is participating in an investigational drug or another investigational device study.

- The subject has another medical condition, which, in the opinion of the investigator, may cause him/her to be noncompliant with the protocol, confound the data interpretation, or is associated with limited life expectancy not sufficient to complete all study procedures.

- The subject has extensive peripheral vascular disease, which, in the opinion of the investigator, precludes safe insertion of an introducer sheath.

- The target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion.

- The subject has angiographic evidence of poor inflow, which would be deemed inadequate to support a vascular bypass graft.

- The subject has severe calcification of the target lesion, which prevents inflation of a PTA balloon (pre-dilatation of the target lesion is required).

- The subject has angiographic evidence of large acute thrombus at the target lesion.

- Subjects with a stent previously implanted into the target lesion. A target vessel with a previously placed stent is permitted as long as the subject device(s) will not come into contact with the previously placed stent during treatment of the target lesion.

- Lesion requiring the use of more than two stents.

- Bilateral disease in the native SFA and/or popliteal artery where both limbs meet the inclusion/exclusion criteria and it is planned to treat both limbs within 30 days. Note: One limb may be enrolled in the study, but only if the second limb is planned to be treated after the 30 day follow-up telephone screening has taken place. The limb that may be enrolled has to be the limb with the more severe lesion and the reasons for treating this specific limb will need to be stated in the case report form (CRF).

- The subject had a prior vascular intervention within 30 days before, or has an intervention planned for within 30 days after the index procedure. Note: Additional non-target lesions may be treated during the index procedure.

Study Design


Intervention

Device:
Bard® LifeStent® 5F Vascular Stent System
The LifeStent® Vascular Stent is a peripheral stent intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and popliteal artery with reference vessel diameters ranging from 4.0 - 6.5 mm.

Locations

Country Name City State
Germany Universitaets-Herzzentrum Freiburg, Klinik fuer Kardiologie und Angiologie II Bad Krozingen Suedring 15
Germany Gemeinschaftspraxis fuer Radiologie Berlin Heinz-Galinski-Str. 1
Germany Fuerst-Stirum-Klinik Bruchsal Bruchsal Gutleutstr. 1-14
Germany Praxis fuer Interventionelle Angiologie Kaiserslautern Strassburger Allee 4

Sponsors (1)

Lead Sponsor Collaborator
C. R. Bard

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Freedom from occurrence of death 30 days post-index procedure
Primary Freedom from occurrence of amputation 30 days post-index procedure
Primary Freedom from TLR (Target Lesion Revascularization) TLR is defined as a revascularization procedure (e.g. PTA, cryoplasty, etc.) of the target lesion. 30 days post-index procedure
Primary Freedom from TVR (Target Vessel Revascularization) TVR is defined as a revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) of the target vessel outside the target lesion. 30 days post-index procedure
Primary Technical success Technical success is defined as successful deployment and placement accuracy based upon a rating scale completed by the investigators. bookend sizes will be evaluated for clinical utility of size range. At the time of index procedure (usually within 10 minutes)
Secondary Freedom from TLR (Target Lesion Revascularization) TLR is defined as a revascularization procedure (e.g. PTA, cryoplasty, etc.) of the target lesion. Up to 12 months post-index procedure
Secondary Freedom from TVR (Target Vessel Revascularization) TVR is defined as a revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) of the target vessel outside the target lesion. Up to 12 months post-index procedure
Secondary Primary patency rates Patency is defined as a reduction in luminal diameter (stenosis) of <=50% and of <=70% measured by Duplex ultrasound (DUS) (peak systolic velocity ratio or PSVR <= 2.4 and <=3.4). Failure of primary patency is defined as a restenosis (reduction in luminal diameter of >50%) as measured by DUS (PSVR >2.4). Up to 12 months post-index procedure
Secondary Freedom from death TLR is defined as a revascularization procedure (e.g. PTA, cryoplasty, etc.) of the target lesion. TVR is defined as a revascularization procedure (e.g. PTA, stenting, surgical bypass, etc.) of the target vessel outside the target lesion. 12 months post-index procedure
Secondary Freedom from occurrence of stroke 12 months post-index procedure
Secondary Freedom from occurrence of MI (myocardial infarction) 12 months post-index procedure
Secondary Occurrence of emergent surgical revascularization of the target limb 12 months post-index procedure
Secondary Occurrence of significant distal embolization in target limb 12 months post-index procedure
Secondary Occurrence of target limb major amputation 12 months post-index procedure
Secondary Occurrence of thrombosis of target vessel 12 months post-index procedure.
See also
  Status Clinical Trial Phase
Recruiting NCT06032065 - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD) Phase 3
Active, not recruiting NCT03987061 - MOTIV Bioresorbable Scaffold in BTK Artery Disease N/A
Recruiting NCT03506633 - Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients N/A
Active, not recruiting NCT03506646 - Dietary Nitrate Supplementation and Thermoregulation N/A
Active, not recruiting NCT04677725 - NEtwork to Control ATherothrombosis (NEAT Registry)
Recruiting NCT05961943 - RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients N/A
Recruiting NCT06047002 - Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
Completed NCT03185052 - Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach N/A
Recruiting NCT05992896 - A Study of Loco-Regional Liposomal Bupivacaine Injection Phase 4
Completed NCT04635501 - AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial N/A
Recruiting NCT04584632 - The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery N/A
Withdrawn NCT03994185 - The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease N/A
Withdrawn NCT03538392 - Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
Recruiting NCT02915796 - Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty Phase 1
Active, not recruiting NCT02900924 - Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
Completed NCT02901847 - To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities. N/A
Not yet recruiting NCT02455726 - Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease N/A
Not yet recruiting NCT02387450 - Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication Phase 2/Phase 3
Withdrawn NCT02126540 - Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries N/A
Completed NCT02022423 - Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease N/A