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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: Laser induced pressure wave calcium modification

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • Onze Lieve Vrouw Ziekenhuis
  • Dendermonde, Belgium
    • AZ Sint Blasius

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single arm	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; Other Names: Laser atherectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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

Collaborators and Investigators

• Sponsor: Spectranetics Corporation

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2017
• Primary Completion (Actual): October 31, 2017
• Study Completion (Actual): March 18, 2018

Study Registration Dates

• First Submitted: July 11, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 31, 2017

Study Record Updates

• Last Update Posted (Actual): April 18, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: peripheral arterial disease; calcium
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: D034698

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No