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

NCT03268018 | Completed

• 1 other identifier: D034698
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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

Keywords

calcium; peripheral arterial disease

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

Single arm

OTHER

Device: Laser induced pressure wave calcium modification

Interventions

Laser induced pressure wave calcium modification 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

Also known as: Laser atherectomy

Single arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spectranetics Corporation: lead

Study Sites (2)

Onze Lieve Vrouw Ziekenhuis

Aalst, 9300, Belgium

Location

AZ Sint Blasius

Dendermonde, Belgium

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: August 31, 2017
• Study Start: June 7, 2017
• Primary Completion: October 31, 2017
• Study Completion: March 18, 2018
• Last Updated: April 18, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)