Prospective, Non-randomized Multi-center, Controlled Physician-initiated Trial: Rotarex Belgium In-stent Occlusion

NCT02212626 | Completed Phase 4

• 1 other identifier: FMRP-130326
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 5

Brief Summary

The objective of this study is to evaluate the safety and efficacy of recanalization of acute and subacute femoropopliteal stent occlusions with the Rotarex S catheter (Straub Medical)

Conditions

Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (2)

• Technical success of the Rotarex device

  Defined as removal of all thrombotic material, documented by angiography pre- and post-procedure: residual stenosis of the lesion \<30%.

  1 day post-op

• Absence of procedure related complications

  Embolization, amputation, perforation or hemorrhage.

  1 day post-op

Secondary Outcomes (4)

• Primary patency at 6 month follow-up

  6 months

• Target Lesion Revascularization (TLR)

  1 and 6 months

• Clinical success

  1 and 6 months

• Serious Adverse Events

  up to 6 months

Study Arms (1)

Rotarex

EXPERIMENTAL

After assessment of the lesion by angiography the occlusion is intraluminally crossed with the wire according to physician's discretion. The device is introduced and the catheter is activated while its tip is still proximal to the occlusion to allow lubrication of the spiral inside the catheter with the aspirated blood. The catheter is advanced into the occlusion with occasional retraction into the already recanalized lumen. Care must be taken to achieve sufficient cooling of the catheter tip and evacuation of the debris to get an appropriate blood flow along the catheter. In order to minimize peripheral embolization of clot the distal end of the occlusion should not be passed too fast before all loose material has been sucked back into the catheter. Several passages of the occlusion may be needed to clean out all wall-adherent thrombotic material. If residual underlying stenosis of \>30% persist further endovascular treatment can be performed according to the physician's discretion.

Device: Rotarex S

Interventions

Rotarex S DEVICE

Rotarex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is willing to comply with specified follow-up evaluations at the specified times
• Patient is \>18 years old
• Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study
• Patient has a projected life-expectancy of at least 6 months
• Symptomatic acute or subacute stent occlusion in the femoropopliteal artery
• Target vessel diameter ≥ 3 mm and ≤ 8 mm
• Patient is candidate for thrombolytic or anticoagulation medication
• Patient is able and willing to comply with study follow-up requirements

You may not qualify if:

• No patent artery until the foot
• Inability of crossing lesion with guidewire
• Known active infection at the time of intervention
• Untreated flow-limiting inflow lesions
• Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrolment
• Aneurysm in the target vessel
• Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol
• Major distal amputation (above the transmetatarsal) in the study limb or non-study limb
• Septicemia or bacteremia
• Any previously known coagulation disorder, including hypercoagulability
• Contraindication to anticoagulation or antiplatelet therapy
• Patient with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
• Currently participating in another clinical research trial
• The patient must be excluded in case any of the following contraindications as listed in the IFU is present:
• Rotarex®S catheters must not be used in case of:

Sponsors & Collaborators

• Flanders Medical Research Program: lead

Study Sites (5)

OLV Hospital

Aalst, 9300, Belgium

Location

Imelda Hospital

Bonheiden, 2820, Belgium

Location

AZ Sint-Blasius

Dendermonde, 9200, Belgium

Location

UZA

Edegem, 2650, Belgium

Location

RZ Heilig Hart Hospital

Tienen, 3300, Belgium

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2014
• First Posted: August 8, 2014
• Study Start: August 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: August 1, 2017

Record last verified: 2017-07

Locations

BE (5)