Clinical trial NCT01095237: Clinical Pilot-Study of ProEndoTecc Vascular Grafts as Superficial Femoral Artery Bypass / Interponate
Official title: Multicenter, Clinical Pilot-Study of ProEndoTecc Vascular Grafts (6, 7 or 8 mm Diameter) as Superficial Femoral Artery Bypass/Interponate
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Peripheral Arterial Disease
Peripheral Vascular Disease
Keywords: Peripheral Arterial Disease
Peripheral Vascular Disease
PAD
vascular prosthesis
revascularization
patency
blood vessel
Rutherford
ABI
Ankle Brachial Index
Vascular Graft
Carbothane
ProEndoTecc
implantation
Lead sponsor: NonWoTecc Medical GmbH
Sponsor class: INDUSTRY
Collaborators: name: MDT Medical Device Testing GmbH
First posted: 2010-03-30
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-center, clinical pilot-study of ProEndoTecc Vascular Grafts (6, 7 or 8 mm Diameter) as superficial femoral artery bypass/interponate.

The aim of this study is to demonstrate safety of implantation, patency and durability of a new type of vascular graft.


Eligibility criteria: Inclusion Criteria:

* Female or male patient from 18 to 89 years of age
* Superficial femoral artery occlusion from 5 to 40 cm in length (above the knee joint),
* Patient must present with intermittent claudication, with resistance to medical therapy and exercise or critical ischemia,
* Patient has Rutherford grade 3, 4, or 5 occlusive vascular disease,
* Women of childbearing age must have negative pregnancy test prior to inclusion

Exclusion Criteria:

* Bleeding diathesis
* Patient has known coagulation disorders including hypercoagulability
* Presence of one or several previously placed endo-prosthesis or grafts in the diseased extremity (below iliacs)
* Other than 6-8 mm diameter graft is needed.
* Patients PAD state is in Fontaine Grade IV, Rutherford Grade 6 (Patient has active infection or pronounced necrosis in the region of graft placement)
* Patient has an acute embolic arterial occlusion
* Life-expectancy less than 6 month due to co-morbidity or other situation that would make the patient an unlikely candidate for follow-up visits
* Patient had percutaneous transluminal angioplasty at the implant site within the previous 30 days
* Participation in another clinical study less than 30 days prior to inclusion
* Patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure
* Pregnant or breast feeding female patients
* Multiple graft (implant) needed
* Patients unable to understand the full meaning of the informed consent
* Subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this trial or will not comply with requirements of the study
* Subjects who are imprisoned (according to MPG §20.3)
* Patients who are lawfully kept in an institution
* Participation in this trial at an earlier stage
* Current participation in another clinical trial

Primary outcomes:
measure: Primary patency of device
timeFrame: 6, 12, 24 months after implatation
Secondary outcomes:
measure: Guarding Safety variables
timeFrame: 6,12, 24 months after implantation
Other outcomes:
Locations:
city: Karlsruhe
country: Germany
facility: Staedtisches Klinikum Karlsruhe gGmbH
state: Baden-Wuerttemberg
city: Deggendorf
country: Germany
facility: Klinikum Deggendorf, Dpt. of Vascular- and Endovascular Surgery
state: Bavaria
city: Muenchen
country: Germany
facility: Hospital Muenchen-Pasing
state: Bavaria
city: Nuernberg
country: Germany
facility: Klinikum Nuernberg Sued Dpt. of Vascular Surgery
state: Bavaria
city: Regensburg
country: Germany
facility: Krankenhaus Barmherzige Brüder, Dpt. of Vascular Surgery
state: Bavaria
city: Lingen
country: Germany
facility: Klinik fuer Gefaesschirurgie St-Bonifatius-Hospital Lingen
state: Lower Saxony
city: Aachen
country: Germany
facility: Luisenhospital Dpt. of Vascular Surgery
state: Nordrhein-Westfalen
city: Bottrop
country: Germany
facility: Knappschaftskrankenhaus Bottrop Dpt. of Vascular Surgery
state: Nordrhein-Westfalen
city: Cologne
country: Germany
facility: Clinic and Polyclinic for Vascular Surgery
state: Nordrhein-Westfalen
city: Muelheim
country: Germany
facility: Evangelisches Krankenhaus Dpt. of Vascular Surgery
state: Nordrhein-Westfalen
city: Remscheid
country: Germany
facility: Sana Clinic Remscheid Dpt. of Vascular Surgery
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: Gefaesschirurgische Klinik St-Marienhospital Bonn
state: North Rhine-Westphalia
Study officials:
References: