Status:
COMPLETED
ModificatiOn and Treatment of stenoseD Calcified inFrainguinal Lesions With Laser atherectomY in a Pilot Study
Lead Sponsor:
Spectranetics Corporation
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The MODIFY Pilot clinical study in Europe looks to evaluate acute and procedural outcomes using a new calcium atherectomy and modification solution in patients with balloon resistant calcified lesions...
Eligibility Criteria
Inclusion
- Patient age ≥ 18 years
- Patient agrees to participate and comply with the protocol by signing an Ethics Committee approved consent form
- Peripheral arterial disease with a documented Rutherford Class 2-5 and
- a resting ankle-brachial index (ABI) of \<0.9 or an abnormal exercise ABI (\<0.75) if resting ABI is normal. Patient with incompressible arteries (ABI \>1.2) must have a toe brachial index (TBI) \<0.7 in target limb;
- or a previous intervention to the target vessels with reoccurrence of symptoms
- Balloon resistant calcific lesion apparent on angiogram by inability to dilate lesion to less than 50% diameter stenosis (DS)
- Lesion to include fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending greater than 1 cm in length
- De novo or restenotic lesion of the SFA, popliteal or infrapopliteal artery
- Minimum reference vessel diameter (RVD) of 2.5mm
- Minimum target lesion length of ≥ 5cm
- At least one patent (\<50% stenosed) runoff vessel to the foot
Exclusion
- Patient is pregnant or breast feeding (Female subjects of childbearing potential must have negative serum pregnancy test 7 days prior to treatment)
- Life expectancy \< 12 months
- Cerebrovascular accident \< 60 days prior to procedure
- Myocardial infarction \< 60 days prior to procedure
- Known contraindication to aspirin, antiplatelet/anti-coagulant therapies required for procedure/follow up
- Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure
- Uncontrolled hypercoagulability or history of HIT or HITT syndrome
- Serum creatinine ≥ 2.5 mg/dL tested within a week prior to procedure
- Patient is simultaneously participating in another investigational drug or device study that will interfere with the 30 day Safety Endpoint
- Patient is not eligible for bypass surgery or endovascular intervention
- Planned major amputation
- Planned or predicted cardiovascular surgical or interventional procedures prior to completion of the 30-day follow-up (including, but not limited to aortic, renal, cardiac, carotid, contralateral femoropopliteal, and contralateral below the knee
- Lesion located within a stent or endograft
- Ipsilateral and/or contralateral iliac (or common femoral) artery stenosis ≥ 50% DS that is not successfully treated prior to index procedure
- Target lesion could not be crossed with the guidewire or support catheter
Key Trial Info
Start Date :
June 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2018
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03268018
Start Date
June 7 2017
End Date
March 18 2018
Last Update
April 18 2019
Active Locations (2)
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1
Onze Lieve Vrouw Ziekenhuis
Aalst, Belgium, 9300
2
AZ Sint Blasius
Dendermonde, Belgium