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

NCT ID: NCT03268018

Last Updated: 2019-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-07
• Study Completion Date: 2018-03-18

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 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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single arm

Group Type: OTHER

Laser induced pressure wave calcium modification

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Laser atherectomy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spectranetics Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Onze Lieve Vrouw Ziekenhuis

Aalst, , Belgium

AZ Sint Blasius

Dendermonde, , Belgium

Countries

Belgium

Other Identifiers

D034698

Identifier Type: -

Identifier Source: org_study_id