Clinical Pilot-Study of ProEndoTecc Vascular Grafts as Superficial Femoral Artery Bypass / Interponate

Peripheral Arterial Disease Clinical Trial

Official title:

Multicenter, Clinical Pilot-Study of ProEndoTecc Vascular Grafts (6, 7 or 8 mm Diameter) as Superficial Femoral Artery Bypass/Interponate

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01095237
• Other study ID #: mdt-09k006
• Status: Terminated
• Phase: N/A
• First received: March 23, 2010
• Last updated: July 8, 2014
• Start date: March 2010
• Est. completion date: November 2012

Study information

• Verified date: July 2014
• Source: NonWoTecc Medical GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• ProEndoTecc Vascular Graft
Implantation of the device as an interponate / bypass of the superficial femoral artery

Locations

Country	Name	City	State
Germany	Luisenhospital Dpt. of Vascular Surgery	Aachen	Nordrhein-Westfalen
Germany	Gefaesschirurgische Klinik St-Marienhospital Bonn	Bonn	North Rhine-Westphalia
Germany	Knappschaftskrankenhaus Bottrop Dpt. of Vascular Surgery	Bottrop	Nordrhein-Westfalen
Germany	Clinic and Polyclinic for Vascular Surgery	Cologne	Nordrhein-Westfalen
Germany	Klinikum Deggendorf, Dpt. of Vascular- and Endovascular Surgery	Deggendorf	Bavaria
Germany	Staedtisches Klinikum Karlsruhe gGmbH	Karlsruhe	Baden-Wuerttemberg
Germany	Klinik fuer Gefaesschirurgie St-Bonifatius-Hospital Lingen	Lingen	Lower Saxony
Germany	Evangelisches Krankenhaus Dpt. of Vascular Surgery	Muelheim	Nordrhein-Westfalen
Germany	Hospital Muenchen-Pasing	Muenchen	Bavaria
Germany	Klinikum Nuernberg Sued Dpt. of Vascular Surgery	Nuernberg	Bavaria
Germany	Krankenhaus Barmherzige Brüder, Dpt. of Vascular Surgery	Regensburg	Bavaria
Germany	Sana Clinic Remscheid Dpt. of Vascular Surgery	Remscheid	Nordrhein-Westfalen

Sponsors (2)

Lead Sponsor	Collaborator
NonWoTecc Medical GmbH	MDT Medical Device Testing GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary patency of device	Primary Patency of treated arterial segment at 6 month after intervention. Primary Patency is defined by objective demonstration via colour-coded Doppler sonography or angiography that the entire length of the graft remain patent with no further intervention required for symptomatic recurrent disease.; In case this information is not available, primary patency might be declared, if any the following criteria are fulfilled: Present ABI increased of =0.1 compared to preoperative status Present PAD-Grade according to Rutherford increased by one degree Palpable pulse distal of prosthesis.	6, 12, 24 months after implatation	No
Secondary	Guarding Safety variables	Peri-interventional monitoring resp. haemorrhages, haematomas; Aneurysm in the grafted segment; Fistula to the grafted segment; Fibrosis at and around implantation site; Death	6,12, 24 months after implantation	Yes