ModificatiOn and Treatment of stenoseD Calcified inFrainguinal Lesions With Laser atherectomY in a Pilot Study

Peripheral Arterial Disease Clinical Trial

— MODIFY  

Official title:

ModificatiOn and Treatment of stenoseD Calcified inFrainguinal Lesions With Laser atherectomY in a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03268018
• Other study ID #: D034698
• Status: Completed
• Phase: N/A
• Start date: June 7, 2017
• Est. completion date: March 18, 2018

Study information

• Verified date: September 2018
• Source: Spectranetics Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 in infrainguinal disease. The intent is to both debulk and modify the vessel to restore blood flow, improve vessel compliance and drive better outcomes. The MODIFY Pilot study will evaluate safety and performance measurements.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 18, 2018
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient age = 18 years

2. Patient agrees to participate and comply with the protocol by signing an Ethics Committee approved consent form

3. Peripheral arterial disease with a documented Rutherford Class 2-5 and

1. 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;

2. or a previous intervention to the target vessels with reoccurrence of symptoms

4. Balloon resistant calcific lesion apparent on angiogram by inability to dilate lesion to less than 50% diameter stenosis (DS)

5. Lesion to include fluoroscopic evidence of calcification: 1) on parallel sides of the vessel and 2) extending greater than 1 cm in length

6. De novo or restenotic lesion of the SFA, popliteal or infrapopliteal artery

7. Minimum reference vessel diameter (RVD) of 2.5mm

8. Minimum target lesion length of = 5cm

9. At least one patent (<50% stenosed) runoff vessel to the foot

Exclusion Criteria:

1. Patient is pregnant or breast feeding (Female subjects of childbearing potential must have negative serum pregnancy test 7 days prior to treatment)

2. Life expectancy < 12 months

3. Cerebrovascular accident < 60 days prior to procedure

4. Myocardial infarction < 60 days prior to procedure

5. Known contraindication to aspirin, antiplatelet/anti-coagulant therapies required for procedure/follow up

6. Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure

7. Uncontrolled hypercoagulability or history of HIT or HITT syndrome

8. Serum creatinine = 2.5 mg/dL tested within a week prior to procedure

9. Patient is simultaneously participating in another investigational drug or device study that will interfere with the 30 day Safety Endpoint

10. Patient is not eligible for bypass surgery or endovascular intervention

11. Planned major amputation

12. 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

13. Lesion located within a stent or endograft

14. Ipsilateral and/or contralateral iliac (or common femoral) artery stenosis = 50% DS that is not successfully treated prior to index procedure

15. Target lesion could not be crossed with the guidewire or support catheter

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Laser induced pressure wave calcium modification
A calcium atherectomy and modification solution in patients with balloon resistant calcified lesions in infrainguinal disease. The intent is to both debulk and modify the vessel to restore blood flow, improve vessel compliance and drive better outcomes

Locations

Country	Name	City	State
Belgium	Onze Lieve Vrouw Ziekenhuis	Aalst
Belgium	AZ Sint Blasius	Dendermonde

Sponsors (1)

Lead Sponsor	Collaborator
Spectranetics Corporation

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary performance defined as minimum lumen diameter measured pre-laser atherectomy and post-calcium modification as well as the ability to dilate a previously balloon resistant lesion after calcium modification procedure	Minimum Lumen Diameter (MLD) measured pre-laser atherectomy and post-calcium modification, as measured by angiography and QVA.; The ability to dilate a previously balloon resistant lesion after calcium modification procedure with low pressure balloon inflation.	Index procedure
Primary	Primary safety as defined as major adverse event (MAE) composite of all cause death, target vessel revascularization and major amputation of the target limb.	Safety outcome through 30-day follow-up (MAE composite): All cause death Target vessel revascularization (TVR) Major amputation of target limb	30 days