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

Primary Purpose

Peripheral Arterial Disease, Peripheral Vascular Disease

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ProEndoTecc Vascular Graft
Sponsored by
NonWoTecc Medical GmbH
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease focused on measuring Peripheral Arterial Disease, Peripheral Vascular Disease, PAD, vascular prosthesis, revascularization, patency, blood vessel, Rutherford, ABI, Ankle Brachial Index, Vascular Graft, Carbothane, ProEndoTecc, implantation

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Staedtisches Klinikum Karlsruhe gGmbH
  • Klinikum Deggendorf, Dpt. of Vascular- and Endovascular Surgery
  • Hospital Muenchen-Pasing
  • Klinikum Nuernberg Sued Dpt. of Vascular Surgery
  • Krankenhaus Barmherzige Brüder, Dpt. of Vascular Surgery
  • Klinik fuer Gefaesschirurgie St-Bonifatius-Hospital Lingen
  • Luisenhospital Dpt. of Vascular Surgery
  • Knappschaftskrankenhaus Bottrop Dpt. of Vascular Surgery
  • Clinic and Polyclinic for Vascular Surgery
  • Evangelisches Krankenhaus Dpt. of Vascular Surgery
  • Sana Clinic Remscheid Dpt. of Vascular Surgery
  • Gefaesschirurgische Klinik St-Marienhospital Bonn

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 23, 2010
Last Updated
July 8, 2014
Sponsor
NonWoTecc Medical GmbH
Collaborators
MDT Medical Device Testing GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01095237
Brief Title
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

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Why Stopped
Study has been halted due to safety reasons
Study Start Date
March 2010 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NonWoTecc Medical GmbH
Collaborators
MDT Medical Device Testing GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
ProEndoTecc Vascular Graft
Other Intervention Name(s)
ProEndoTecc Vascular Graft Prosthesis
Intervention Description
Implantation of the device as an interponate / bypass of the superficial femoral artery
Primary Outcome Measure Information:
Title
Primary patency of device
Description
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.
Time Frame
6, 12, 24 months after implatation
Secondary Outcome Measure Information:
Title
Guarding Safety variables
Description
Peri-interventional monitoring resp. haemorrhages, haematomas Aneurysm in the grafted segment Fistula to the grafted segment Fibrosis at and around implantation site Death
Time Frame
6,12, 24 months after implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Staedtisches Klinikum Karlsruhe gGmbH
City
Karlsruhe
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
76133
Country
Germany
Facility Name
Klinikum Deggendorf, Dpt. of Vascular- and Endovascular Surgery
City
Deggendorf
State/Province
Bavaria
ZIP/Postal Code
94469
Country
Germany
Facility Name
Hospital Muenchen-Pasing
City
Muenchen
State/Province
Bavaria
ZIP/Postal Code
81241
Country
Germany
Facility Name
Klinikum Nuernberg Sued Dpt. of Vascular Surgery
City
Nuernberg
State/Province
Bavaria
ZIP/Postal Code
90471
Country
Germany
Facility Name
Krankenhaus Barmherzige Brüder, Dpt. of Vascular Surgery
City
Regensburg
State/Province
Bavaria
ZIP/Postal Code
93049
Country
Germany
Facility Name
Klinik fuer Gefaesschirurgie St-Bonifatius-Hospital Lingen
City
Lingen
State/Province
Lower Saxony
ZIP/Postal Code
49808
Country
Germany
Facility Name
Luisenhospital Dpt. of Vascular Surgery
City
Aachen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Knappschaftskrankenhaus Bottrop Dpt. of Vascular Surgery
City
Bottrop
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
46242
Country
Germany
Facility Name
Clinic and Polyclinic for Vascular Surgery
City
Cologne
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Evangelisches Krankenhaus Dpt. of Vascular Surgery
City
Muelheim
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45468
Country
Germany
Facility Name
Sana Clinic Remscheid Dpt. of Vascular Surgery
City
Remscheid
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
42859
Country
Germany
Facility Name
Gefaesschirurgische Klinik St-Marienhospital Bonn
City
Bonn
State/Province
North Rhine-Westphalia
ZIP/Postal Code
53115
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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